Sheppard Mullin's Health-e Law

A podcast dedicated to the exciting, and sometimes explosive, interaction between technology and law in the health space, covering innovations that impact healthcare, like artificial intelligence, virtual reality, and wearables. Hosted by Sheppard Mullin’s Digital Health Team, the Health-e Law podcast will dive into the legal implications of health-tech you should know about and visit with trailblazing players in the industry.

AI in Clinical Research: Opportunities, Risks, and the Road Ahead with Bill Kish and Dr. Brad Pruitt of Kenosha AI 07/24/2025

AI in Clinical Research: Opportunities, Risks, and the Road Ahead with Bill Kish and Dr. Brad Pruitt of Kenosha AI Welcome to Health-e Law, Sheppard Mullin's podcast exploring the fascinating health tech topics and trends of the day. In this episode, Sara Shanti welcomes Bill Kish and Dr. Brad Pruitt of Kenosha AI to explore how artificial intelligence can enhance efficiency and compliance in healthcare research. What is Kenosha AI, and what is its potential role in transforming healthcare and research operations? Who are the end users of Kenosha AI’s products, and how are these products positioned to deliver immediate, tangible impacts for their missions? Looking ahead, how might this momentum build, and what direction could clinical research take with the advancements enabled by AI? What are the risks and concerns associated with hallucinations, synthetic data, and the trustworthiness of AI deliverables? Where can healthcare stakeholders feel comfortable jumping in on AI, and where does it make sense to wait for further development? What tasks should clinicians and researchers prioritize when exploring the potential applications of AI? About Bill Kish is the CEO and Co-Founder of Kenosha AI, bringing over 30 years of dynamic experience as a technologist, entrepreneur, and leader across five successful startups. His expertise has led burgeoning companies to flourish into multi-billion-dollar enterprises, solidifying his position as an industry innovator. A graduate with honors in Computer Engineering from Carnegie Mellon University, Bill’s career has been defined by groundbreaking advancements in AI and machine learning applications. He co-founded Ruckus Wireless, serving as CTO and Board Director, where his contributions shaped the company into a $400M/year business and a leader in the wireless technology industry, culminating in a $1.5 billion acquisition by Brocade. At Cogniac Corporation, Bill enabled industries to leverage AI-powered visual inspection, serving as the CEO and CTO to drive operational innovation. He also founded Jiggy AI, a boutique AI consulting firm specializing in large language model applications. Additionally, as the organizer of the Silicon Valley Machine Learning Meetup, Bill has fostered a thriving global community of over 10,000 members passionate about machine learning. About Dr. Brad Pruitt is the President and Co-Founder of Kenosha AI. With over 25 years of experience in clinical research and healthcare, including 13 years in the Contract Research Organization (CRO) industry, he specializes in revolutionizing clinical trials through advanced AI-powered tools like copilots and GPTs. Dr. Pruitt is a seasoned executive and entrepreneur with a proven track record of leading ventures to success. He has held executive roles at top-tier CROs, served as the Founding CEO of an acquired startup, and contributed to three successful acquisitions in the past eight years. His prior leadership roles include Chief Medical Officer at Alethium Health Systems, where he developed go-to-market strategies for clinical trial innovation, and Senior Vice President of Medical Affairs at Safe Health, where he drove business expansion into connected diagnostics. In addition to his role with Kenosha AI, Dr. Pruitt is a Principal at Prucor and serves as a mentor and advisor for healthcare and clinical trial technology companies participating in the EvoNexus incubator program. Dr. Pruitt earned his MD from Michigan State University College of Human Medicine and his MBA from UC San Diego’s Rady School of Management. His academic foundation, combined with his professional achievements, positions him as a visionary leader at the intersection of technology, healthcare, and clinical research. About Sara Shanti A partner in the Corporate Practice Group in Sheppard Mullin's Chicago office and co-lead of its Digital Health Team, practice sits at the forefront of healthcare technology by providing practical counsel on novel innovation and complex data privacy matters. Using her medical research background and HHS experience, Sara advises providers, payors, start-ups, technology companies, and their investors and stakeholders on digital healthcare and regulatory compliance matters, including artificial intelligence (AI), augmented and virtual reality (AR/VR), gamification, implantable and wearable devices, and telehealth. At the cutting edge of advising on "data as an asset" programming, Sara's practice supports investment in innovation and access to care initiatives, including mergers and acquisitions involving crucial, high-stakes and sensitive data, medical and wellness devices, and web-based applications and care. Contact Information Additional Resources - Kenosha AI is currently offering a free trial of its RegChatTM, which is an AI-powered Clinical Regulatory Guidance Assistant that provides a simple chat interface for answering questions about global regulatory guidance using AI and official regulatory guidance documents with referenced summarizations and multi-agency comparisons. Find it at . Thank you for listening! Don't forget to SUBSCRIBE to the show to receive new episodes delivered straight to your podcast player every month. If you enjoyed this episode, please help us get the word out about this podcast. Rate and Review this show on , , or . It helps other listeners find this show. This podcast is for informational and educational purposes only. It is not to be construed as legal advice specific to your circumstances. If you need help with any legal matter, be sure to consult with an attorney regarding your specific needs. /episode/index/show/d148bbc4-cc5a-41b1-8595-41e12e629d0e/id/37535715

Navigating AI: Governance and Innovation at UCSD Health with Ron Skillens of UCSD Health 04/21/2025

Navigating AI: Governance and Innovation at UCSD Health with Ron Skillens of UCSD Health Welcome to Health-e Law, Sheppard Mullin's podcast exploring the fascinating health tech topics and trends of the day. In this episode, Ron Skillens, Chief Compliance and Privacy Officer at UC San Diego Health, joins host and Sheppard Mullin partner Michael Orlando to discuss the transformative potential of AI in healthcare and the importance of balancing innovation with compliance. What We Discussed in This Episode: How could AI transform patient care and hospital operations in the next five years? With health data being as sensitive and valuable as it is, why is an AI governance structure crucial for the creative and compliant use of AI? How can AI usage be effectively managed and coordinated between stakeholders to strike the right balance of innovation and risk? What have been some of the biggest challenges and lessons learned when establishing an AI governance structure? In what ways does patient interest shape the evaluation of AI applications in healthcare? What is the best way to keep staff and stakeholders updated on the latest AI advancements, emerging trends and best practices? About Ron Skillens Ron Skillens is the chief compliance and privacy officer for UC San Diego Health. He is responsible for the mitigation of compliance and regulatory risks, pursuing leading practices and ensuring that all Health compliance and privacy activities are coordinated with the appropriate leaders. In addition, Mr. Skillens provides health care research compliance support for UC San Diego Health Sciences and is responsible for administering the health system’s policy and procedure process. He has more than 30 years of compliance, audit and risk management experience working with diverse senior leadership, physicians and boards, bringing to this position a demonstrated commitment to compliance and collaboration. About Michael Orlando is a corporate and intellectual property transactions partner in Sheppard Mullin’s San Diego (Del Mar) office. He is Co-Team Leader of the firm's Technology Transactions Team, and a member of the Life Sciences and Digital Health teams. He founded a software-as-a-service (SaaS) business prior to attending law school, and worked at a publicly-traded biotechnology company on an in-house secondment, and uses that experience in bringing a practical, business-oriented approach to his engagements. For over 20 years, Michael has been assisting innovators, cutting-edge technology companies and other organizations develop, acquire, sell, and commercialize intellectual property assets, including technology licensing, commercial agreements, strategic partnerships, research, development and collaboration contracts, manufacturing and supply arrangements, outsourcing, and corporate transactions. Contact Information Additional Resources Thank you for listening! Don't forget to SUBSCRIBE to the show to receive new episodes delivered straight to your podcast player every month. If you enjoyed this episode, please help us get the word out about this podcast. Rate and Review this show on , , or . It helps other listeners find this show. This podcast is for informational and educational purposes only. It is not to be construed as legal advice specific to your circumstances. If you need help with any legal matter, be sure to consult with an attorney regarding your specific needs. /episode/index/show/d148bbc4-cc5a-41b1-8595-41e12e629d0e/id/36250770

Crossroads of Care: Navigating Executive Orders with Jonathan Meyer, former DHS GC and Partner at Sheppard Mullin 02/25/2025

Crossroads of Care: Navigating Executive Orders with Jonathan Meyer, former DHS GC and Partner at Sheppard Mullin Welcome to Health-e Law, Sheppard Mullin's podcast exploring the fascinating health tech topics and trends of the day. In this episode, Jonathan Meyer, a partner at Sheppard Mullin and Leader of the firm’s National Security Team, joins us again to discuss the early days of the new Trump administration and what might be on the horizon in terms of cybersecurity and data privacy. What We Discussed in This Episode: What can we expect from the new administration in relation to cybersecurity and data protection? How do these concerns translate to healthcare, both in terms of managing our care and protecting our data? What is Sheppard Mullin’s executive actions tracker, why it matters, and how can listeners use it? How is healthcare struggling with privacy and immigration, and how does this impact national security? About Jonathan Meyer As a partner in Sheppard Mullin’s Governmental Practice Group and leader of the firm’s National Security team, counsels clients on their interactions with federal and state government, as well as national and homeland security, Congressional oversight, cybersecurity, AI, high tech, and transportation security, among other issues. Prior to returning to Sheppard Mullin, Jon was nominated by President Biden and confirmed by the Senate as the Sixth General Counsel of the U.S. Department of Homeland Security, serving from 2021 to 2024. His decades of experience in Congress, the Justice Department and DHS position him to bring an insider’s perspective to interactions between private companies and the government. He has defended scores of Congressional investigations and has prepared witnesses for over 100 hearings, including Supreme Court nomination hearings, impeachment hearings, oversight hearings, high tech and antitrust investigations, and civil rights investigations, among others. He has also represented defendants and witnesses in high-stakes Justice Department criminal investigations. The media – including CBS News, NPR, The Wall Street Journal, The New York Times, The Washington Post and Politico – regularly turn to Jon for insight into issues regarding national security, homeland security, government investigations, cybersecurity, immigration, politics and Congress. He has twice been honored with the Secretary of Homeland Security’s Outstanding Service Medal, the highest civilian award bestowed by DHS. He has also received the U.S. Secret Service Director’s Honor Award, the Customs and Border Protection Commissioner’s Ensign Award, and the U.S. Coast Guard Commandant’s Distinguished Service Medal, among numerous other prestigious accolades recognizing his exceptional service. About Sara Shanti A partner in the Corporate Practice Group in the Sheppard Mullin's Chicago office and co-lead of its Digital Health Team, practice sits at the forefront of healthcare technology by providing practical counsel on novel innovation and complex data privacy matters. Using her medical research background and HHS experience, Sara advises providers, payors, start-ups, technology companies, and their investors and stakeholders on digital healthcare and regulatory compliance matters, including artificial intelligence (AI), augmented and virtual reality (AR/VR), gamification, implantable and wearable devices, and telehealth. At the cutting edge of advising on "data as an asset" programming, Sara's practice supports investment in innovation and access to care initiatives, including mergers and acquisitions involving crucial, high-stakes and sensitive data, medical and wellness devices, and web-based applications and care. Contact Information Additional Resources Thank you for listening! Don't forget to SUBSCRIBE to the show to receive new episodes delivered straight to your podcast player every month. If you enjoyed this episode, please help us get the word out about this podcast. Rate and Review this show on , , or . It helps other listeners find this show. This podcast is for informational and educational purposes only. It is not to be construed as legal advice specific to your circumstances. If you need help with any legal matter, be sure to consult with an attorney regarding your specific needs. /episode/index/show/d148bbc4-cc5a-41b1-8595-41e12e629d0e/id/35428795

Healthcare Security is Homeland Security with Jonathan Meyer, former DHS GC and Partner at Sheppard Mullin 02/05/2025

Healthcare Security is Homeland Security with Jonathan Meyer, former DHS GC and Partner at Sheppard Mullin Welcome to Health-e Law, Sheppard Mullin's podcast exploring the fascinating health tech topics and trends of the day. In this episode, Jonathan Meyer, former general counsel of the Department of Homeland Security and Leader of Sheppard Mullin’s National Security Team, joins us to discuss cyberthreats and data security from the perspective of national security, including the implications for healthcare. What We Discussed In This Episode How do cyberattacks and data privacy impact national security? How can personal data be weaponized to cause harm to an individual, and why should people care? Many adults are aware they need to keep their own personal data secure for financial reasons, but what about those who aren’t financially active, such as children? How is healthcare particularly vulnerable to cyberthreats, even outside the hospital setting? What can stakeholders do better at the healthcare level? What can individuals do better to ensure their personal data remains secure? About Jonathan Meyer As a partner in Sheppard Mullin’s Governmental Practice Group and leader of the firm’s National Security team, counsels clients on their interactions with federal and state government, as well as national and homeland security, Congressional oversight, cybersecurity, AI, high tech, and transportation security, among other issues. Prior to returning to Sheppard Mullin, Jon was nominated by President Biden and confirmed by the Senate as the Sixth General Counsel of the U.S. Department of Homeland Security, serving from 2021 to 2024. His decades of experience in Congress, the Justice Department and DHS position him to bring an insider’s perspective to interactions between private companies and the government. He has defended scores of Congressional investigations and has prepared witnesses for over 100 hearings, including Supreme Court nomination hearings, impeachment hearings, oversight hearings, high tech and antitrust investigations, and civil rights investigations, among others. He has also represented defendants and witnesses in high-stakes Justice Department criminal investigations. The media – including CBS News, NPR, The Wall Street Journal, The New York Times, The Washington Post and Politico – regularly turn to Jon for insight into issues regarding national security, homeland security, government investigations, cybersecurity, immigration, politics and Congress. He has twice been honored with the Secretary of Homeland Security’s Outstanding Service Medal, the highest civilian award bestowed by DHS. He has also received the U.S. Secret Service Director’s Honor Award, the Customs and Border Protection Commissioner’s Ensign Award, and the U.S. Coast Guard Commandant’s Distinguished Service Medal, among numerous other prestigious accolades recognizing his exceptional service. About Sara Shanti A partner in the Corporate Practice Group in the Sheppard Mullin's Chicago office and co-lead of its Digital Health Team, practice sits at the forefront of healthcare technology by providing practical counsel on novel innovation and complex data privacy matters. Using her medical research background and HHS experience, Sara advises providers, payors, start-ups, technology companies, and their investors and stakeholders on digital healthcare and regulatory compliance matters, including artificial intelligence (AI), augmented and virtual reality (AR/VR), gamification, implantable and wearable devices, and telehealth. At the cutting edge of advising on "data as an asset" programming, Sara's practice supports investment in innovation and access to care initiatives, including mergers and acquisitions involving crucial, high-stakes and sensitive data, medical and wellness devices, and web-based applications and care. Contact Information Thank you for listening! Don't forget to SUBSCRIBE to the show to receive new episodes delivered straight to your podcast player every month. If you enjoyed this episode, please help us get the word out about this podcast. Rate and Review this show on , , or . It helps other listeners find this show. This podcast is for informational and educational purposes only. It is not to be construed as legal advice specific to your circumstances. If you need help with any legal matter, be sure to consult with an attorney regarding your specific needs. /episode/index/show/d148bbc4-cc5a-41b1-8595-41e12e629d0e/id/35162625

The Future (of Healthcare) is Female with Danielle Vrabie and Amanda Zablocki, Co-Chairs of Sheppard Mullin’s WHLC 12/06/2024

The Future (of Healthcare) is Female with Danielle Vrabie and Amanda Zablocki, Co-Chairs of Sheppard Mullin’s WHLC Welcome to Health-e Law, Sheppard Mullin's podcast exploring the fascinating health tech topics and trends of the day. In this episode, Danielle Vrabie and Amanda Zablocki, partners at Sheppard Mullin and Co-Chairs of the firm’s Women in Healthcare Leadership Collaborative (WHLC), join Sara Shanti to talk about the importance of elevating women to leadership roles in healthcare. What We Discussed in this Episode: Women make up about 75% of entry-level positions in healthcare. Women make up about 32% of executive-level positions in healthcare and less than 5% are women of color. What inspired the founding of WHLC six years ago? What is WHLC’s mission? What does the growth of WHLC indicate for the evolving industry? What was the focus of WHLC’s First Annual Leadership Summit held last month? Why are women’s voices so important in terms of healthcare industry leadership? How might promoting people with frontline healthcare experience help mitigate litigation risks facing the industry? Why is it important to promote women leaders in sectors that intersect with healthcare? What will 2025 look like for WHLC? About Danielle Vrabie is a partner in the Litigation Practice Group in Sheppard Mullin’s New York office and a member of the firm’s Healthcare and Life Sciences Teams. Danielle represents corporate clients and individuals in complex commercial litigation and government investigations throughout the country. A substantial portion of her practice is dedicated to serving healthcare and life sciences clients, including hospitals and health systems, physician and specialty practice groups, managed care organizations, pharmaceutical companies, long-term care providers, and medical device companies. She has experience representing these clients in a variety of contexts, including commercial disputes and litigation, enforcement actions, and government investigations. She also has significant experience defending against investigations and litigation involving allegations under the False Claims Act, Stark Law, Anti-Kickback Statute, and similar anti-fraud statutes. In this context, she also assists companies in conducting internal investigations regarding allegations of fraud, employee misconduct, and whistleblower complaints and developing cost-effective and practical compliance and risk management programs. Danielle also helped establish and serves as Co-Chair of WHLC, which seeks to promote the advancement of women in the healthcare industry by bringing them together in a supportive community and providing them with targeted education focused on complex legal issues, healthcare innovation, and other critical issues. About Amanda Zablocki A partner in Sheppard Mullin’s New York office, is a trusted legal and strategic advisor to healthcare organizations across the country, helping them achieve their goals while navigating a dynamic regulatory landscape. Amanda leads complex healthcare deals, including mergers and acquisitions, joint ventures and strategic partnerships, corporate reorganizations, and value-based care arrangements. She routinely advises on a range of healthcare and nonprofit regulatory matters, including fraud, waste, and abuse, the corporate practice of medicine, nonprofit law, tax exemption, corporate governance, and compliance matters. Her clients conclude health plans and health insurers, hospitals, academic medical centers, digital health and healthcare technology companies, integrated healthcare delivery systems, pharmaceutical and life sciences companies, rare disease organizations, independent practice associations, physician practices, management services organizations, value-based enterprises, care management organizations, and 501(c)(3) organizations. In addition to helping found and serving as Co-Chair of WHLC, Amanda has devoted substantial time to supporting the recruitment, retention, and advancement of women in the legal industry. She served as Co-Chair of the New York Women Lawyers’ Group (WLG) for several years before joining the firm’s WLG National Leadership Council. In her role as Chair of Sheppard Mullin’s New York Recruiting Committee, Amanda cultivates the next generation of attorneys through the firm’s highly ranked summer associate program. About Sara Shanti A partner in the Corporate Practice Group in the Sheppard Mullin's Chicago office and co-lead of its Digital Health Team, practice sits at the forefront of healthcare technology by providing practical counsel on novel innovation and complex data privacy matters. Using her medical research background and HHS experience, Sara advises providers, payors, start-ups, technology companies, and their investors and stakeholders on digital healthcare and regulatory compliance matters, including artificial intelligence (AI), augmented and virtual reality (AR/VR), gamification, implantable and wearable devices, and telehealth. At the cutting edge of advising on "data as an asset" programming, Sara's practice supports investment in innovation and access to care initiatives, including mergers and acquisitions involving crucial, high-stakes and sensitive data, medical and wellness devices, and web-based applications and care. Contact Info Resources Thank you for listening! Don't forget to SUBSCRIBE to the show to receive new episodes delivered straight to your podcast player every month. If you enjoyed this episode, please help us get the word out about this podcast. Rate and Review this show on , , or . It helps other listeners find this show. This podcast is for informational and educational purposes only. It is not to be construed as legal advice specific to your circumstances. If you need help with any legal matter, be sure to consult with an attorney regarding your specific needs. /episode/index/show/d148bbc4-cc5a-41b1-8595-41e12e629d0e/id/34318670

Overcoming Challenges to Innovation in Preventative Care with Steven Collens of MATTER 10/10/2024

Overcoming Challenges to Innovation in Preventative Care with Steven Collens of MATTER Welcome to Health-e Law, Sheppard Mullin's podcast exploring the fascinating health tech topics and trends of the day. In this episode, Steven Collens, CEO of a global healthcare innovation hub based in Chicago, joins us to explore advancements in preventative care and the innovations driving this transformation. What We Discussed in this Episode: What markers for success does MATTER look for? What type of entrepreneurs does MATTER seek? How is innovation moving policy/creating policy? What creative solutions for novel products have had early success in securing reimbursement? How do tech innovators ensure their technology has a patient-first mentality? About Steven Collens is CEO of MATTER, a premier healthcare incubator and innovation hub. MATTER opened in February 2015 and nurtures entrepreneurs and innovators to build next-generation health IT, medical devices, as well as diagnostic and biopharma technologies. MATTER has worked with more than 1,000 healthcare technology ventures, and the company partners with dozens of industry-leading companies, health systems and universities. Prior to assuming his current role, Steven was senior vice president at Pritzker Group, the investment firm led by Tony and J.B. Pritzker. In that capacity, he led the team that created 1871, Chicago’s center for digital startups, which became the top-ranked business incubator in the world in 2018. He previously worked at Abbott in a variety of domestic and international functions, including product management, policy, and public affairs. In 2005, Steven helped found to give patients control over their health data and allow healthcare providers to coordinate care of their patients. Prior to Abbott, Steven served as legislative assistant to U.S. Senator Carol Moseley-Braun. Steven holds an MBA from Northwestern University’s Kellogg School of Management and a BA from Washington University in St. Louis. He chairs the board of Hubbard Street Dance Chicago and serves on the boards of 1871 and the Chicago High School for the Arts. He is a member of ChicagoNEXT, the Chicago mayor’s council on technology and innovation, a Leadership Greater Chicago fellow, and a member of the Economic Club of Chicago and the Commercial Club of Chicago. About Sara Shanti A partner in the Corporate Practice Group in the Sheppard Mullin's Chicago office and co-lead of its Digital Health Team, practice sits at the forefront of healthcare technology by providing practical counsel on novel innovation and complex data privacy matters. Using her medical research background and HHS experience, Sara advises providers, payors, start-ups, technology companies, and their investors and stakeholders on digital healthcare and regulatory compliance matters, including artificial intelligence (AI), augmented and virtual reality (AR/VR), gamification, implantable and wearable devices, and telehealth. At the cutting edge of advising on "data as an asset" programming, Sara's practice supports investment in innovation and access to care initiatives, including mergers and acquisitions involving crucial, high-stakes and sensitive data, medical and wellness devices, and web-based applications and care. About Phil Kim A partner in the Corporate and Securities Practice Group in Sheppard Mullin's Dallas office and co-lead of its Digital Health Team, has a number of clients in digital health. He has assisted multinational technology companies entering the digital health space with various service and collaboration agreements for their wearable technology, along with global digital health companies bolstering their platform in the behavioral health space. He also assists public medical device, biotechnology, and pharmaceutical companies, as well as the investment banks that serve as underwriters in public securities offerings for those companies. Phil also assists various healthcare companies on transactional and regulatory matters. He counsels healthcare systems, hospitals, ambulatory surgery centers, physician groups, home health providers, and other healthcare companies on the buy- and sell-side of mergers and acquisitions, joint ventures, and operational matters, which include regulatory, licensure, contractual, and administrative issues. Phil regularly advises clients on matters related to healthcare compliance, including liability exposure, the Stark law, anti-kickback statutes, and HIPAA/HITECH privacy issues. He also provides counsel on state and federal laws, business structuring formation, employment issues, and involving government agencies, including state and federal agencies. Contact Info Resources Thank you for listening! Don't forget to SUBSCRIBE to the show to receive new episodes delivered straight to your podcast player every month. If you enjoyed this episode, please help us get the word out about this podcast. Rate and Review this show on , , or . It helps other listeners find this show. This podcast is for informational and educational purposes only. It is not to be construed as legal advice specific to your circumstances. If you need help with any legal matter, be sure to consult with an attorney regarding your specific needs. /episode/index/show/d148bbc4-cc5a-41b1-8595-41e12e629d0e/id/33395157

Healthcare Needs More Hackers with Ilona Cohen of HackerOne 09/26/2024

Healthcare Needs More Hackers with Ilona Cohen of HackerOne Welcome to Health-e Law, Sheppard Mullin's podcast exploring the fascinating health tech topics and trends of the day. In this episode, Sheppard Mullin’s Phil Kim, Sara Shanti and Michael D. Sutton are joined by Ilona Cohen, Chief Legal Officer and Chief Policy Officer of HackerOne, to discuss creative and inspiring solutions for addressing the surge of data breaches in healthcare. What We Discussed in this Episode: What does “data breach” mean in the healthcare context? What is driving the recent surge of threat actors targeting healthcare? How are healthcare stakeholders mitigating these risks? How is breached data being monetized or laundered back into legitimate businesses? What exposures should businesses be alert for after a breach? Can you tell us a bit about HackerOne and the work you do? What is ethical hacking? Has the healthcare sector embraced it? About Ilona Cohen was formerly a senior lawyer to President Obama and served as General Counsel of the White House Office of Management and Budget (OMB). Highly experienced with cybersecurity and ethical hacking solutions, she was part of a core group in the White House responsible for the development of President Obama’s long-term strategy to enhance cybersecurity awareness and protection in the public and private sectors. These efforts resulted in the launch of the first U.S. government bug bounty program, Hack The Pentagon, run by HackerOne. Prior to joining HackerOne in July 2022, Ilona served as Chief Legal and Compliance Officer at Aledade, another venture-backed tech company, where she successfully built and scaled the company’s legal and compliance teams. At HackerOne, she’s leveraging her extensive experience to build out the public policy team, mature the legal function to support expanded growth and provide strategic leadership to the rest of the company. About Sara Shanti A partner in the Corporate Practice Group in the Sheppard Mullin's Chicago office and co-lead of its Digital Health Team, practice sits at the forefront of healthcare technology by providing practical counsel on novel innovation and complex data privacy matters. Using her medical research background and HHS experience, Sara advises providers, payors, start-ups, technology companies, and their investors and stakeholders on digital healthcare and regulatory compliance matters, including artificial intelligence (AI), augmented and virtual reality (AR/VR), gamification, implantable and wearable devices, and telehealth. At the cutting edge of advising on "data as an asset" programming, Sara's practice supports investment in innovation and access to care initiatives, including mergers and acquisitions involving crucial, high-stakes and sensitive data, medical and wellness devices, and web-based applications and care. About Phil Kim A partner in the Corporate and Securities Practice Group in Sheppard Mullin's Dallas office and co-lead of its Digital Health Team, has a number of clients in digital health. He has assisted multinational technology companies entering the digital health space with various service and collaboration agreements for their wearable technology, along with global digital health companies bolstering their platform in the behavioral health space. He also assists public medical device, biotechnology, and pharmaceutical companies, as well as the investment banks that serve as underwriters in public securities offerings for those companies. Phil also assists various healthcare companies on transactional and regulatory matters. He counsels healthcare systems, hospitals, ambulatory surgery centers, physician groups, home health providers, and other healthcare companies on the buy- and sell-side of mergers and acquisitions, joint ventures, and operational matters, which include regulatory, licensure, contractual, and administrative issues. Phil regularly advises clients on matters related to healthcare compliance, including liability exposure, the Stark law, anti-kickback statutes, and HIPAA/HITECH privacy issues. He also provides counsel on state and federal laws, business structuring formation, employment issues, and involving government agencies, including state and federal agencies. About Michael D. Sutton As an associate in the Corporate Practice Group at Sheppard Mullin’s Dallas office, specializes in cutting-edge and disruptive areas of practice, blending healthcare, technology, and legal compliance. In particular, he focuses on HIPAA and privacy regulations, considering their relationship with technological advancements in both healthcare and consumer sectors. He is skilled in negotiations regarding data usage and ownership rights, guiding clients on marketing or integrating technological innovations while navigating emerging regulations in digital healthcare, including artificial intelligence, web tracking, information blocking, offshoring, and de-identification. Michael has managed investigations, worked to resolve active breach incidents, and advised clients on healthcare privacy and technology matters. He supports clients navigating HIPAA and other privacy laws to ensure their objectives are achieved within all legal and regulatory requirements. Michael also provides comprehensive regulatory services to a range of healthcare participants, including investors, managed care organizations, health plans, and medical groups. In particular, he has tackled operational and contractual negotiations, licensing, compliance, and fraud considerations and conducted regulatory due diligence for transactions, including mergers and acquisitions. Michael also supports transactions involving tech companies and healthcare providers, guiding negotiations related to software and service relationships while identifying vulnerabilities in targets and devising creative solutions to address them. Contact Info Resources Thank you for listening! Don't forget to SUBSCRIBE to the show to receive new episodes delivered straight to your podcast player every month. If you enjoyed this episode, please help us get the word out about this podcast. Rate and Review this show on , , or . It helps other listeners find this show. This podcast is for informational and educational purposes only. It is not to be construed as legal advice specific to your circumstances. If you need help with any legal matter, be sure to consult with an attorney regarding your specific needs. /episode/index/show/d148bbc4-cc5a-41b1-8595-41e12e629d0e/id/33206562

CURES and Beyond: Reining in the Long Tail of Healthcare with Gregory Stein of Shadowbox 07/18/2024

CURES and Beyond: Reining in the Long Tail of Healthcare with Gregory Stein of Shadowbox Welcome to Health-e Law, Sheppard Mullin's podcast exploring the fascinating health tech topics and trends of the day. In this episode, Gregory Stein, Founder, Chief Executive Officer, and Director of Shadowbox, joins us to discuss how the 21st Century Cures Act could impact interplay within the healthcare industry, particularly interoperability as a means of addressing what has become, according to recent testimony before the U.S. Senate Budget Committee, a $950 billion administrative burden. What We Discussed in This Episode Why was Shadowbox founded, and how is its technology poised to impact the long tail of healthcare? How have the Cures Act and other recent regulations been a game changer? Where is the IT vendor industry headed in terms of adapting to the Cures Act requirements and interoperability? What are some existing disparities between those inside and outside the regulatory certified health IT framework that could create additional gaps in the industry and the ability to access quality care? Beyond the potential for catastrophic health consequences, what other gaps have arisen as the industry has continued to evolve? How should regulators go about addressing some of these gaps? About Gregory A. Stein is the Founder, Chief Executive Officer, and Director of Shadowbox, a venture funded healthcare software company whose mission is to elevate patient care by making patient data easy to access and safe to share no matter where it resides. A former legislative aide on Capitol Hill, Greg was an original investor in Millennium Health and previously served as the company’s Vice President of Strategic and Community Affairs, helping it grow to over 1,500 employees and $1.8BN in enterprise value. Beyond the boardroom, Greg has dedicated his career to community service. He co-founded the Safe Homes Coalition to battle prescription drug abuse and served as Chairman of the San Diego County Taxpayers Association for seven years, leading the charge for better government efficiency. About Sara Shanti A partner in the Corporate Practice Group in the Sheppard Mullin's Chicago office and co-lead of its Digital Health Team, practice sits at the forefront of healthcare technology by providing practical counsel on novel innovation and complex data privacy matters. Using her medical research background and HHS experience, Sara advises providers, payors, start-ups, technology companies, and their investors and stakeholders on digital healthcare and regulatory compliance matters, including artificial intelligence (AI), augmented and virtual reality (AR/VR), gamification, implantable and wearable devices, and telehealth. At the cutting edge of advising on "data as an asset" programming, Sara's practice supports investment in innovation and access to care initiatives, including mergers and acquisitions involving crucial, high-stakes and sensitive data, medical and wellness devices, and web-based applications and care. About Phil Kim A partner in the Corporate and Securities Practice Group in Sheppard Mullin's Dallas office and co-lead of its Digital Health Team, has a number of clients in digital health. He has assisted multinational technology companies entering the digital health space with various service and collaboration agreements for their wearable technology, along with global digital health companies bolstering their platform in the behavioral health space. He also assists public medical device, biotechnology, and pharmaceutical companies, as well as the investment banks that serve as underwriters in public securities offerings for those companies. Phil also assists various healthcare companies on transactional and regulatory matters. He counsels healthcare systems, hospitals, ambulatory surgery centers, physician groups, home health providers, and other healthcare companies on the buy- and sell-side of mergers and acquisitions, joint ventures, and operational matters, which include regulatory, licensure, contractual, and administrative issues. Phil regularly advises clients on matters related to healthcare compliance, including liability exposure, the Stark law, anti-kickback statutes, and HIPAA/HITECH privacy issues. He also provides counsel on state and federal laws, business structuring formation, employment issues, and involving government agencies, including state and federal agencies. Contact Info Resources Thank you for listening! Don't forget to SUBSCRIBE to the show to receive new episodes delivered straight to your podcast player every month. If you enjoyed this episode, please help us get the word out about this podcast. Rate and Review this show on , , or . It helps other listeners find this show. This podcast is for informational and educational purposes only. It is not to be construed as legal advice specific to your circumstances. If you need help with any legal matter, be sure to consult with an attorney regarding your specific needs. /episode/index/show/d148bbc4-cc5a-41b1-8595-41e12e629d0e/id/32187662

Assessing Data Assets in Healthcare with Arti Bedi Pullins of QuestionPro 06/27/2024

Assessing Data Assets in Healthcare with Arti Bedi Pullins of QuestionPro Welcome to Health-e Law, Sheppard Mullin's podcast exploring the fascinating health tech topics and trends of the day. In this episode, Arti Bedi Pullins, President and Chief Healthcare Officer at QuestionPro, joins us to discuss how the healthcare sector is increasingly recognizing and leveraging data as an asset, including how data is being collected for value-based or outcome-based payment models. What We Discussed in this Episode: How is data being recognized as an asset in the healthcare sector? What are some really interesting and valuable areas where healthcare data is being collected today? How are industry players balancing patient privacy concerns with commercial interests? How crucial is data integrity, and how is transparency being communicated to engage consumers and patients? How is healthcare data being collected for value-based or outcome-based payment models? What other exciting opportunities have emerged in terms of data collection and leveraging data as an asset in healthcare? About Arti Pullins is a strategic, data-driven entrepreneur with 20+ years of experience in leading business strategy, product innovation, digital marketing and end-to-end divisional deployment for Healthcare, HealthTech, Health & Wellness and Tech companies. Her passion sits at the intersection of customer-based design thinking, innovative technology and accurate market data and research. She is President and Chief Healthcare Officer of QuestionPro. Throughout her 19-year career, Arti has architected and led over a dozen technology companies toward double and triple-digit growth by applying market, customer and product research to understand how consumers impact brand engagement and adoption. Prior to founding Pundit Consultantz, which was recently acquired by QuestionPro, she held senior leadership roles with SessionM, Glassdoor and CareerBuilder.com. Arti holds an MBA from the Kellogg School of Management at Northwestern University and a bachelor’s degree in sociology and communications from Michigan State University. About Sara Shanti A partner in the Corporate Practice Group in the Sheppard Mullin's Chicago office and co-lead of its Digital Health Team, practice sits at the forefront of healthcare technology by providing practical counsel on novel innovation and complex data privacy matters. Using her medical research background and HHS experience, Sara advises providers, payors, start-ups, technology companies, and their investors and stakeholders on digital healthcare and regulatory compliance matters, including artificial intelligence (AI), augmented and virtual reality (AR/VR), gamification, implantable and wearable devices, and telehealth. At the cutting edge of advising on "data as an asset" programming, Sara's practice supports investment in innovation and access to care initiatives, including mergers and acquisitions involving crucial, high-stakes and sensitive data, medical and wellness devices, and web-based applications and care. About Phil Kim A partner in the Corporate and Securities Practice Group in Sheppard Mullin's Dallas office and co-lead of its Digital Health Team, has a number of clients in digital health. He has assisted multinational technology companies entering the digital health space with various service and collaboration agreements for their wearable technology, along with global digital health companies bolstering their platform in the behavioral health space. He also assists public medical device, biotechnology, and pharmaceutical companies, as well as the investment banks that serve as underwriters in public securities offerings for those companies. Phil also assists various healthcare companies on transactional and regulatory matters. He counsels healthcare systems, hospitals, ambulatory surgery centers, physician groups, home health providers, and other healthcare companies on the buy- and sell-side of mergers and acquisitions, joint ventures, and operational matters, which include regulatory, licensure, contractual, and administrative issues. Phil regularly advises clients on matters related to healthcare compliance, including liability exposure, the Stark law, anti-kickback statutes, and HIPAA/HITECH privacy issues. He also provides counsel on state and federal laws, business structuring formation, employment issues, and involving government agencies, including state and federal agencies. Contact Info Thank you for listening! Don't forget to SUBSCRIBE to the show to receive new episodes delivered straight to your podcast player every month. If you enjoyed this episode, please help us get the word out about this podcast. Rate and Review this show on , , or . It helps other listeners find this show. This podcast is for informational and educational purposes only. It is not to be construed as legal advice specific to your circumstances. If you need help with any legal matter, be sure to consult with an attorney regarding your specific needs. /episode/index/show/d148bbc4-cc5a-41b1-8595-41e12e629d0e/id/31915472

Remote Patient Monitoring Innovating Health Tech with Dr. Vipul Kella of Physio AI 05/02/2024

Remote Patient Monitoring Innovating Health Tech with Dr. Vipul Kella of Physio AI Welcome to Health-e Law, Sheppard Mullin's podcast exploring the fascinating health tech topics and trends of the day. In this episode, Vipul Kella, M.D., Chief Medical Officer at Physio AI, joins us to discuss how innovations in remote patient monitoring (RPM) are revolutionizing the healthcare landscape. What We Discussed in This Episode: From a provider’s perspective, what are you seeing in terms of innovation? How do you see innovations in RPM driving real-time improvements in outcomes? Where does RPM technology come up short, and where can it be improved? Would you say we’ve reached RPM 2.0? As a practitioner, what would you like RPM 2.0 to look like? What needs to happen from a reimbursement perspective? What do you see as RPM’s role in monitoring and tracking value-based outcomes? About Vipul Kella, M.D. A Board-Certified Emergency Medicine physician, has extensive experience working with healthcare-focused industries, health tech companies, and hospitals to deliver results through revenue optimization, value-based solutions, digital marketing, remote physiologic monitoring, go-to-market strategy, and other advisory activities. He earned his M.D. at the University of Toledo and holds an MBA with an emphasis on Healthcare Administration from Johns Hopkins University, where he pursued an interest in Standard of Care and Administration, policy and decision-making in hospitals, and healthcare facilities from a business perspective. About Sara Shanti A partner in the Corporate Practice Group in the Sheppard Mullin's Chicago office and co-lead of its Digital Health Team, practice sits at the forefront of healthcare technology by providing practical counsel on novel innovation and complex data privacy matters. Using her medical research background and HHS experience, Sara advises providers, payors, start-ups, technology companies, and their investors and stakeholders on digital healthcare and regulatory compliance matters, including artificial intelligence (AI), augmented and virtual reality (AR/VR), gamification, implantable and wearable devices, and telehealth. At the cutting edge of advising on "data as an asset" programming, Sara's practice supports investment in innovation and access to care initiatives, including mergers and acquisitions involving crucial, high-stakes and sensitive data, medical and wellness devices, and web-based applications and care. About Phil Kim A partner in the Corporate and Securities Practice Group in Sheppard Mullin's Dallas office and co-lead of its Digital Health Team, has a number of clients in digital health. He has assisted multinational technology companies entering the digital health space with various service and collaboration agreements for their wearable technology, along with global digital health companies bolstering their platform in the behavioral health space. He also assists public medical device, biotechnology, and pharmaceutical companies, as well as the investment banks that serve as underwriters in public securities offerings for those companies. Phil also assists various healthcare companies on transactional and regulatory matters. He counsels healthcare systems, hospitals, ambulatory surgery centers, physician groups, home health providers, and other healthcare companies on the buy- and sell-side of mergers and acquisitions, joint ventures, and operational matters, which include regulatory, licensure, contractual, and administrative issues. Phil regularly advises clients on matters related to healthcare compliance, including liability exposure, the Stark law, anti-kickback statutes, and HIPAA/HITECH privacy issues. He also provides counsel on state and federal laws, business structuring formation, employment issues, and involving government agencies, including state and federal agencies. Contact Info Thank you for listening! Don't forget to SUBSCRIBE to the show to receive new episodes delivered straight to your podcast player every month. If you enjoyed this episode, please help us get the word out about this podcast. Rate and Review this show on , , or . It helps other listeners find this show. This podcast is for informational and educational purposes only. It is not to be construed as legal advice specific to your circumstances. If you need help with any legal matter, be sure to consult with an attorney regarding your specific needs. /episode/index/show/d148bbc4-cc5a-41b1-8595-41e12e629d0e/id/31087708

What We Heard at HIMSS 2024 with Michael Orlando & Carolyn Metnick 04/18/2024

What We Heard at HIMSS 2024 with Michael Orlando & Carolyn Metnick Welcome to Health-e Law, Sheppard Mullin's podcast exploring the fascinating health-tech topics and trends of the day. In this episode, Sheppard Mullin partners Carolyn Metnick and Michael Orlando join Phil Kim to discuss the firm’s experience at HIMSS Global Health Conference 2024 in Orlando. The conference is one of the leading health IT educational gatherings and draws visionary CIOs, top-level executives, dedicated healthcare providers, and health IT professionals to cover the latest trends in digital health, including AI and cybersecurity. What We Discussed in this Episode: Were there any noticeable shifts in vendors from HIMSS 2024? What sort of role did AI play in this year's conference? How were conversations around AI different this year versus last year? How can AI help with healthcare equity and patient disparities? What was the discussion around cybersecurity? How can ocular imaging technology change the business model for healthcare delivery and patient care? About Carolyn Metnick is a partner in Sheppard Mullin’s Corporate Practice Group in the firm's Chicago office and a member of the Healthcare and Privacy & Cybersecurity Teams. Carolyn represents a range of healthcare industry clients, including hospitals and health systems, physician organizations and digital health companies. She advises on healthcare regulatory and transactional matters, focusing on health information privacy and security. Carolyn advises clients on a range of privacy and security laws, including HIPAA and the California Consumer Privacy Act (CCPA). She also counsels businesses in data breach investigations and compliance with federal and state breach notification laws. Carolyn is a Certified Information Privacy Professional/United States (CIPP/US) and a Certified Information Privacy Professional/Europe (CIPP/E). Carolyn also represents healthcare industry clients in transactional matters, guiding clients through joint ventures, mergers and acquisitions, and advising on healthcare regulatory issues. Her background as a former litigator helps inform her transactional work. About Michael Orlando is a corporate and intellectual property transactions partner in the firm's San Diego (Del Mar) office. He is Co-Team Leader of the firm's Technology Transactions Team, and a member of the Life Sciences and Digital Health teams. He founded a software-as-a-service (SaaS) business prior to attending law school, and worked at a publicly-traded biotechnology company on an in-house secondment, and uses that experience in bringing a practical, business-oriented approach to his engagements. For over 20 years he has been assisting innovators, cutting-edge technology companies and other organizations develop, acquire, sell, and commercialize intellectual property assets, including technology licensing, commercial agreements, strategic partnerships, research, development and collaboration contracts, manufacturing and supply arrangements, outsourcing, and corporate transactions. About Phil Kim A partner in the Corporate and Securities Practice Group in Sheppard Mullin's Dallas office and co-lead of its Digital Health Team, has a number of clients in digital health. He has assisted multinational technology companies entering the digital health space with various service and collaboration agreements for their wearable technology, along with global digital health companies bolstering their platform in the behavioral health space. He also assists public medical device, biotechnology, and pharmaceutical companies, as well as the investment banks that serve as underwriters in public securities offerings for those companies. Phil also assists various healthcare companies on transactional and regulatory matters. He counsels healthcare systems, hospitals, ambulatory surgery centers, physician groups, home health providers, and other healthcare companies on the buy- and sell-side of mergers and acquisitions, joint ventures, and operational matters, which include regulatory, licensure, contractual, and administrative issues. Phil regularly advises clients on matters related to healthcare compliance, including liability exposure, the Stark law, anti-kickback statutes, and HIPAA/HITECH privacy issues. He also provides counsel on state and federal laws, business structuring formation, employment issues, and involving government agencies, including state and federal agencies. Contact Information Thank you for listening! Don't forget to SUBSCRIBE to the show to receive new episodes delivered straight to your podcast player every month. If you enjoyed this episode, please help us get the word out about this podcast. Rate and Review this show on , , or . It helps other listeners find this show. This podcast is for informational and educational purposes only. It is not to be construed as legal advice specific to your circumstances. If you need help with any legal matter, be sure to consult with an attorney regarding your specific needs. /episode/index/show/d148bbc4-cc5a-41b1-8595-41e12e629d0e/id/30875483

Health Vibes at ViVE with Sara Shanti and Carolyn Metnick 03/21/2024

Health Vibes at ViVE with Sara Shanti and Carolyn Metnick Welcome to Health-e Law, Sheppard Mullin's podcast exploring the fascinating health-tech topics and trends of the day. Our digital health legal team, alongside brilliant experts and thought leaders, share how innovations can solve some of healthcare’s (and maybe the world’s) biggest problems if properly navigated. In this special episode, partners Sara Shanti and Caroline Metnick join Phil Kim to discuss Sheppard Mullin’s recent attendance at ViVE 2024, the premier conference for digital health innovators primarily focusing on optimizing patient care and improving the patient user experience. What We Discussed in this Episode: What were some notable takeaways from ViVE 2024? How is AI poised to improve healthcare delivery? How might virtual care models help reduce burnout among clinicians and improve access to care? How were the perils of AI addressed, particularly its potential to perpetuate healthcare bias? Including automating bias. Why is ethical AI governance critical in healthcare? How is data driving both opportunity and risk in the healthcare sector? How stakeholders struggle with data fragmentation and data as a valued asset. About Carolyn Metnick is a partner in Sheppard Mullin’s Corporate Practice Group in the firm's Chicago office and a member of the Healthcare and Privacy & Cybersecurity Teams. Carolyn represents a range of healthcare industry clients, including hospitals and health systems, physician organizations and digital health companies. She advises on healthcare regulatory and transactional matters, focusing on health information privacy and security. Carolyn advises clients on a range of privacy and security laws, including HIPAA and the California Consumer Privacy Act (CCPA). She also counsels businesses in data breach investigations and compliance with federal and state breach notification laws. Carolyn is a Certified Information Privacy Professional/United States (CIPP/US) and a Certified Information Privacy Professional/Europe (CIPP/E). Carolyn also represents healthcare industry clients in transactional matters, guiding clients through joint ventures, mergers and acquisitions, and advising on healthcare regulatory issues. Her background as a former litigator helps inform her transactional work. About Sara Shanti A partner in the Corporate Practice Group in the Sheppard Mullin's Chicago office and co-lead of its Digital Health Team, practice sits at the forefront of healthcare technology by providing practical counsel on novel innovation and complex data privacy matters. Using her medical research background and HHS experience, Sara advises providers, payors, start-ups, technology companies, and their investors and stakeholders on digital healthcare and regulatory compliance matters, including artificial intelligence (AI), augmented and virtual reality (AR/VR), gamification, implantable and wearable devices, and telehealth. At the cutting edge of advising on "data as an asset" programming, Sara's practice supports investment in innovation and access to care initiatives, including mergers and acquisitions involving crucial, high-stakes and sensitive data, medical and wellness devices, and web-based applications and care. About Phil Kim A partner in the Corporate and Securities Practice Group in Sheppard Mullin's Dallas office and co-lead of its Digital Health Team, has a number of clients in digital health. He has assisted multinational technology companies entering the digital health space with various service and collaboration agreements for their wearable technology, along with global digital health companies bolstering their platform in the behavioral health space. He also assists public medical device, biotechnology, and pharmaceutical companies, as well as the investment banks that serve as underwriters in public securities offerings for those companies. Phil also assists various healthcare companies on transactional and regulatory matters. He counsels healthcare systems, hospitals, ambulatory surgery centers, physician groups, home health providers, and other healthcare companies on the buy- and sell-side of mergers and acquisitions, joint ventures, and operational matters, which include regulatory, licensure, contractual, and administrative issues. Phil regularly advises clients on matters related to healthcare compliance, including liability exposure, the Stark law, anti-kickback statutes, and HIPAA/HITECH privacy issues. He also provides counsel on state and federal laws, business structuring formation, employment issues, and involving government agencies, including state and federal agencies. Contact Information Thank you for listening! Don't forget to SUBSCRIBE to the show to receive new episodes delivered straight to your podcast player every month. If you enjoyed this episode, please help us get the word out about this podcast. Rate and Review this show on , , , or . It helps other listeners find this show. This podcast is for informational and educational purposes only. It is not to be construed as legal advice specific to your circumstances. If you need help with any legal matter, be sure to consult with an attorney regarding your specific needs. /episode/index/show/d148bbc4-cc5a-41b1-8595-41e12e629d0e/id/30478808

FemTech Meets DiagnosTech with Deirdre O’Neill of Hertility Health 03/07/2024

FemTech Meets DiagnosTech with Deirdre O’Neill of Hertility Health Welcome to Health-e Law, Sheppard Mullin's podcast exploring the fascinating health-tech topics and trends of the day. Our digital health legal team, alongside brilliant experts and thought leaders, share how innovations can solve some of healthcare’s (and maybe the world’s) biggest problems if properly navigated. In this episode, Deirdre O’Neill of joins us to discuss the growing role of DiagnosTech in fertility and reproductive health. What We Discussed in This Episode: What challenges and opportunities do you see on the horizon? What positive trends have emerged due to the changes we’ve witnessed in this millennium? Can you discuss some of the amazing collaborations Hertility Health is engaged in? How might Hertility’s mission be impacted by technology and other industry players moving into the space? Can you explain the concept of DiagnosTech? About Deirdre O’Neill is the Chief Commercial & Legal Officer at Hertility Health, a women’s healthcare startup offering unique diagnostic testing that provides advanced, data-driven insights into reproductive health, fertility decline and the onset of menopause. A dual-qualified lawyer in England and Ireland, Deirdra holds a Master's Degree in Medical Law from King’s College London. After working in Venture Capital Law, she decided to enter the world of startups full-time and subsequently co-founded Hertility, where she currently oversees corporate strategy and deals with legal, scaling, and business operations. About Sara Shanti A partner in the Corporate Practice Group in the Sheppard Mullin's Chicago office and co-lead of its Digital Health Team, practice sits at the forefront of healthcare technology by providing practical counsel on novel innovation and complex data privacy matters. Using her medical research background and HHS experience, Sara advises providers, payors, start-ups, technology companies, and their investors and stakeholders on digital healthcare and regulatory compliance matters, including artificial intelligence (AI), augmented and virtual reality (AR/VR), gamification, implantable and wearable devices, and telehealth. At the cutting edge of advising on "data as an asset" programming, Sara's practice supports investment in innovation and access to care initiatives, including mergers and acquisitions involving crucial, high-stakes and sensitive data, medical and wellness devices, and web-based applications and care. About Phil Kim A partner in the Corporate and Securities Practice Group in Sheppard Mullin's Dallas office and co-lead of its Digital Health Team, has a number of clients in digital health. He has assisted multinational technology companies entering the digital health space with various service and collaboration agreements for their wearable technology, along with global digital health companies bolstering their platform in the behavioral health space. He also assists public medical device, biotechnology, and pharmaceutical companies, as well as the investment banks that serve as underwriters in public securities offerings for those companies. Phil also assists various healthcare companies on transactional and regulatory matters. He counsels healthcare systems, hospitals, ambulatory surgery centers, physician groups, home health providers, and other healthcare companies on the buy- and sell-side of mergers and acquisitions, joint ventures, and operational matters, which include regulatory, licensure, contractual, and administrative issues. Phil regularly advises clients on matters related to healthcare compliance, including liability exposure, the Stark law, anti-kickback statutes, and HIPAA/HITECH privacy issues. He also provides counsel on state and federal laws, business structuring formation, employment issues, and involving government agencies, including state and federal agencies. Contact Info: Resources: Thank you for listening! Don't forget to SUBSCRIBE to the show to receive new episodes delivered straight to your podcast player every month. If you enjoyed this episode, please help us get the word out about this podcast. Rate and Review this show on , , , or . It helps other listeners find this show. This podcast is for informational and educational purposes only. It is not to be construed as legal advice specific to your circumstances. If you need help with any legal matter, be sure to consult with an attorney regarding your specific needs. /episode/index/show/d148bbc4-cc5a-41b1-8595-41e12e629d0e/id/30273478

Gamification: Playing for Health with Craig Lund of Mightier 02/15/2024

Gamification: Playing for Health with Craig Lund of Mightier Welcome to Health-e Law, Sheppard Mullin's podcast exploring the fascinating health-tech topics and trends of the day. Our digital health legal team, alongside brilliant experts and thought leaders, share how innovations can solve some of healthcare’s (and maybe the world’s) biggest problems, if properly navigated. In this episode, Craig Lund, co-founder and CEO of Mightier, joins us to discuss the role of gamification in healthcare, including its potential to improve both access to care and patient engagement. What We Discussed in This Episode: What is gamification in healthcare? What solutions does gamification offer that the healthcare industry would otherwise struggle to provide? How can gamification improve access to mental and behavioral health services? How might gamification help overcome some of the stigma that often prevents kids and their families from engaging with mental health services? How do you see gamification growing across the broader healthcare industry? What must be done to ensure healthcare consumers can access these solutions and to ensure they are affordable? What are you most excited about for the future? About Craig Lund Craig Lund is co-founder and CEO of Mightier, an innovative bio-responsive platform that helps children develop emotional calming and coping skills through fun video game play. Before co-founding the company in 2016, Craig served as interim CEO of Selux Diagnostics, a company transforming antibiotic medicine, and the Chief Commercial Officer of 1366 Technologies, a solar company out of MIT. From 2004 to 2006, he worked for the US Department of Defense in Iraq to launch the government securities market and for Endeavor Argentina, where he helped entrepreneurs start new businesses. He is a graduate of Dartmouth College and Harvard Business School. About Sara Shanti A partner in the Corporate Practice Group in the Sheppard Mullin's Chicago office and co-lead of its Digital Health Team, practice sits at the forefront of healthcare technology by providing practical counsel on novel innovation and complex data privacy matters. Using her medical research background and HHS experience, Sara advises providers, payors, start-ups, technology companies, and their investors and stakeholders on digital healthcare and regulatory compliance matters, including artificial intelligence (AI), augmented and virtual reality (AR/VR), gamification, implantable and wearable devices, and telehealth. At the cutting edge of advising on "data as an asset" programming, Sara's practice supports investment in innovation and access to care initiatives, including mergers and acquisitions involving crucial, high-stakes and sensitive data, medical and wellness devices, and web-based applications and care. About Phil Kim A partner in the Corporate and Securities Practice Group in Sheppard Mullin's Dallas office and co-lead of its Digital Health Team, has a number of clients in digital health. He has assisted multinational technology companies entering the digital health space with various service and collaboration agreements for their wearable technology, along with global digital health companies bolstering their platform in the behavioral health space. He also assists public medical device, biotechnology, and pharmaceutical companies, as well as the investment banks that serve as underwriters in public securities offerings for those companies. Phil also assists various healthcare companies on transactional and regulatory matters. He counsels healthcare systems, hospitals, ambulatory surgery centers, physician groups, home health providers, and other healthcare companies on the buy- and sell-side of mergers and acquisitions, joint ventures, and operational matters, which include regulatory, licensure, contractual, and administrative issues. Phil regularly advises clients on matters related to healthcare compliance, including liability exposure, the Stark law, anti-kickback statutes, and HIPAA/HITECH privacy issues. He also provides counsel on state and federal laws, business structuring formation, employment issues, and involving government agencies, including state and federal agencies. Contact Info: Resources: Thank you for listening! Don't forget to SUBSCRIBE to the show to receive new episodes delivered straight to your podcast player every month. If you enjoyed this episode, please help us get the word out about this podcast. Rate and Review this show on , , , or . It helps other listeners find this show. This podcast is for informational and educational purposes only. It is not to be construed as legal advice specific to your circumstances. If you need help with any legal matter, be sure to consult with an attorney regarding your specific needs. /episode/index/show/d148bbc4-cc5a-41b1-8595-41e12e629d0e/id/29957763

What to Watch for in ‘24: Costs, Consolidation and Tech with Eric Klein of Sheppard Mullin 01/18/2024

What to Watch for in ‘24: Costs, Consolidation and Tech with Eric Klein of Sheppard Mullin Welcome to Health-e Law, Sheppard Mullin's podcast exploring the fascinating health-tech topics and trends of the day. Our digital health legal team, alongside brilliant experts and thought leaders, share how innovations can solve some of healthcare’s (and maybe the world’s) biggest problems, if properly navigated. In this episode, Sheppard Mullin healthcare team leader Eric Klein joins us to discuss the future of health tech and what we can expect to see in 2024. What We Discussed in this Episode: Where is healthcare disruption expected in 2024 and how will that impact costs? Where is digital health headed in 2024? Where will it have the most significant impact? What are savvy investors looking for in 2024? How can industry players make themselves more attractive to investors? What should providers, payers, and industry stakeholders consider as they look to make tech investments? How will the expected wave of consolidation impact the digital health space? About Eric Klein With over 35 years of practical legal and business experience, is widely acknowledged as one of the most experienced attorneys in population health management, physician alignment, and global risk transactions. As a partner in Sheppard Mullin’s Century City Office, he leads the firm’s distinguished national healthcare practice, which has been honored as a Law360 U.S. Health Care Practice Group of the Year three times in the past seven years. Over the last decade, Eric has advised on over 85 hospital mergers, acquisitions, and joint ventures, more than 85 health plan mergers and acquisitions, and many of the country’s largest physician services transactions, establishing him as one of the nation’s most active physician group, health plan and hospital M&A and joint venture lawyers. About Sara Shanti A partner in the Corporate Practice Group in the Sheppard Mullin's Chicago office and co-lead of its Digital Health Team, practice sits at the forefront of healthcare technology by providing practical counsel on novel innovation and complex data privacy matters. Using her medical research background and HHS experience, Sara advises providers, payors, start-ups, technology companies, and their investors and stakeholders on digital healthcare and regulatory compliance matters, including artificial intelligence (AI), augmented and virtual reality (AR/VR), gamification, implantable and wearable devices, and telehealth. At the cutting edge of advising on "data as an asset" programming, Sara's practice supports investment in innovation and access to care initiatives, including mergers and acquisitions involving crucial, high-stakes and sensitive data, medical and wellness devices, and web-based applications and care. About Phil Kim A partner in the Corporate and Securities Practice Group in Sheppard Mullin's Dallas office and co-lead of its Digital Health Team, has a number of clients in digital health. He has assisted multinational technology companies entering the digital health space with various service and collaboration agreements for their wearable technology, along with global digital health companies bolstering their platform in the behavioral health space. He also assists public medical device, biotechnology, and pharmaceutical companies, as well as the investment banks that serve as underwriters in public securities offerings for those companies. Phil also assists various healthcare companies on transactional and regulatory matters. He counsels healthcare systems, hospitals, ambulatory surgery centers, physician groups, home health providers, and other healthcare companies on the buy- and sell-side of mergers and acquisitions, joint ventures, and operational matters, which include regulatory, licensure, contractual, and administrative issues. Phil regularly advises clients on matters related to healthcare compliance, including liability exposure, the Stark law, anti-kickback statutes, and HIPAA/HITECH privacy issues. He also provides counsel on state and federal laws, business structuring formation, employment issues, and involving government agencies, including state and federal agencies. Contact Info: Resources: Thank you for listening! Don't forget to SUBSCRIBE to the show to receive new episodes delivered straight to your podcast player every month. If you enjoyed this episode, please help us get the word out about this podcast. Rate and Review this show on , , , or . It helps other listeners find this show. This podcast is for informational and educational purposes only. It is not to be construed as legal advice specific to your circumstances. If you need help with any legal matter, be sure to consult with an attorney regarding your specific needs. /episode/index/show/d148bbc4-cc5a-41b1-8595-41e12e629d0e/id/29534123

Digital Health to the Rescue: Improving Access to Specialized Care with Viveka Rydell-Anderson of Pacific Vision Foundation 12/07/2023

Digital Health to the Rescue: Improving Access to Specialized Care with Viveka Rydell-Anderson of Pacific Vision Foundation Welcome to Health-e Law, Sheppard Mullin's podcast addressing the fascinating health-tech topics and trends of the day. Our digital health legal team, alongside brilliant experts and thought leaders, share how innovations can solve some of healthcare’s (and maybe the world’s) biggest problems, if properly navigated. In this episode, Viveka Rydell-Anderson, CEO of Pacific Vision Foundation, joins us to discuss the critical need for specialized care and how emerging digital technologies can help overcome access challenges. What We Discussed In This Episode What specifically is specialized care? How is new and emerging technology transforming specialized care? Where are we today in terms of access? How can the industry transition from “sick care” to “healthcare”? Do you see patients embracing this technology? What do developers need to consider as they seek to meet patients' needs? What are you hearing from providers? What do they want from technology? What technologies, including in FemTech, do you see as poised to make a difference and mitigate stigmas? From a lawyer's perspective, how do you see businesses having to adapt and navigate what's ahead of them? About Viveka Rydell-Anderson With over 20 years of experience as a lawyer, healthcare executive and innovator, is a passionate trailblazer in the realm of healthcare equity and access. Viveka is the CEO of Pacific Vision Foundation and the president of the HIMSS Northern California Chapter. She has deep experience in FemTech and specialized care spaces, among her many other impressive achievements, including holding a Master of Science in Clinical Informatics Management from Stanford University School of Medicine in addition to her law degree from UC Berkeley. Before taking on her current role, Viveka spent 14 years as CEO of PDI Surgery Center, a nonprofit Ambulatory Surgery Center providing specialty dental care to children and special needs patients in 30+ California counties. She then co-founded two MedTech startups: ImageChain.ai and Mamsen Health. About Sara Shanti A partner in the Corporate Practice Group in the Sheppard Mullin's Chicago office and co-lead of its Digital Health Team, practice sits at the forefront of healthcare technology by providing practical counsel on novel innovation and complex data privacy matters. Using her medical research background and HHS experience, Sara advises providers, payors, start-ups, technology companies, and their investors and stakeholders on digital healthcare and regulatory compliance matters, including artificial intelligence (AI), augmented and virtual reality (AR/VR), gamification, implantable and wearable devices, and telehealth. At the cutting edge of advising on "data as an asset" programming, Sara's practice supports investment in innovation and access to care initiatives, including mergers and acquisitions involving crucial, high-stakes and sensitive data, medical and wellness devices, and web-based applications and care. About Phil Kim A partner in the Corporate and Securities Practice Group in Sheppard Mullin's Dallas office and co-lead of its Digital Health Team, has a number of clients in digital health. He has assisted multinational technology companies entering the digital health space with various service and collaboration agreements for their wearable technology, along with global digital health companies bolstering their platform in the behavioral health space. He also assists public medical device, biotechnology, and pharmaceutical companies, as well as the investment banks that serve as underwriters in public securities offerings for those companies. Phil also assists various healthcare companies on transactional and regulatory matters. He counsels healthcare systems, hospitals, ambulatory surgery centers, physician groups, home health providers, and other healthcare companies on the buy- and sell-side of mergers and acquisitions, joint ventures, and operational matters, which include regulatory, licensure, contractual, and administrative issues. Phil regularly advises clients on matters related to healthcare compliance, including liability exposure, the Stark law, anti-kickback statutes, and HIPAA/HITECH privacy issues. He also provides counsel on state and federal laws, business structuring formation, employment issues, and involving government agencies, including state and federal agencies. Contact Info: Additional Resources Thank you for listening! Don't forget to SUBSCRIBE to the show to receive new episodes delivered straight to your podcast player every month. If you enjoyed this episode, please help us get the word out about this podcast. Rate and Review this show on , , , or . It helps other listeners find this show. This podcast is for informational and educational purposes only. It is not to be construed as legal advice specific to your circumstances. If you need help with any legal matter, be sure to consult with an attorney regarding your specific needs. /episode/index/show/d148bbc4-cc5a-41b1-8595-41e12e629d0e/id/28966253

AI as an Aid: Emerging Uses in Healthcare with Jim Gatto of Sheppard Mullin 12/07/2023

AI as an Aid: Emerging Uses in Healthcare with Jim Gatto of Sheppard Mullin Welcome to Health-e Law, Sheppard Mullin's podcast addressing the fascinating health-tech topics and trends of the day. Our digital health legal team, alongside brilliant experts and thought-leaders, share how innovations can solve some of healthcare’s (and maybe the world’s) biggest problems, if properly navigated. In this episode, Sheppard Mullin partner Jim Gatto, co-chair of its AI Team, joins us to discuss the AI revolution in healthcare, including how it is enhancing and improving the industry while navigating ethical and legal risks. What We Discussed In This Episode How is AI impacting healthcare today? Why are we seeing an explosion of AI, especially in healthcare, now? Looking forward, where are you seeing AI growing in applications? How will AI impact and improve access to care, particularly in terms of elder care and the epidemic of isolation? What are some of the most significant risks or legal issues that arise from the confluence of AI and healthcare? About James G. Gatto is a partner in the Intellectual Property Practice Group in Sheppard Mullin’s Washington, D.C. office, where he also serves as Co-Leader of the firm’s Artificial Intelligence Team and Leader of the Open Source Team. Jim’s practice focuses on AI, blockchain, interactive entertainment and open source. He provides strategic advice on all aspects of intellectual property strategy and enforcement, technology transactions, licenses, and tech-related regulatory issues, especially ones driven by new business models and/or disruptive technologies. Jim has over two decades of experience advising clients on AI issues and is an adjunct professor who teaches a course on Artificial Intelligence Legal Issues. He is considered a thought-leader on legal issues associated with emerging technologies and business models, most recently blockchain, AI, open source, and interactive entertainment. About Sara Shanti A partner in the Corporate Practice Group in the Sheppard Mullin's Chicago office and co-lead of its Digital Health Team, practice sits at the forefront of healthcare technology by providing practical counsel on novel innovation and complex data privacy matters. Using her medical research background and HHS experience, Sara advises providers, payors, start-ups, technology companies, and their investors and stakeholders on digital healthcare and regulatory compliance matters, including artificial intelligence (AI), augmented and virtual reality (AR/VR), gamification, implantable and wearable devices, and telehealth. At the cutting edge of advising on "data as an asset" programming, Sara's practice supports investment in innovation and access to care initiatives, including mergers and acquisitions involving crucial, high-stakes and sensitive data, medical and wellness devices, and web-based applications and care. About Phil Kim A partner in the Corporate and Securities Practice Group in Sheppard Mullin's Dallas office and co-lead of its Digital Health Team, has a number of clients in digital health. He has assisted multinational technology companies entering the digital health space with various service and collaboration agreements for their wearable technology, along with global digital health companies bolstering their platform in the behavioral health space. He also assists public medical device, biotechnology, and pharmaceutical companies, as well as the investment banks that serve as underwriters in public securities offerings for those companies. Phil also assists various healthcare companies on transactional and regulatory matters. He counsels healthcare systems, hospitals, ambulatory surgery centers, physician groups, home health providers, and other healthcare companies on the buy- and sell-side of mergers and acquisitions, joint ventures, and operational matters, which include regulatory, licensure, contractual, and administrative issues. Phil regularly advises clients on matters related to healthcare compliance, including liability exposure, the Stark law, anti-kickback statutes, and HIPAA/HITECH privacy issues. He also provides counsel on state and federal laws, business structuring formation, employment issues, and involving government agencies, including state and federal agencies. Contact Info: Additional Resources Thank you for listening! Don't forget to SUBSCRIBE to the show to receive new episodes delivered straight to your podcast player every month. If you enjoyed this episode, please help us get the word out about this podcast. Rate and Review this show on , , , or . It helps other listeners find this show. This podcast is for informational and educational purposes only. It is not to be construed as legal advice specific to your circumstances. If you need help with any legal matter, be sure to consult with an attorney regarding your specific needs. /episode/index/show/d148bbc4-cc5a-41b1-8595-41e12e629d0e/id/28966223

In Tech We Trust? The Case for Transparency with Dr. Laura Tully of ChatOwl 12/07/2023

In Tech We Trust? The Case for Transparency with Dr. Laura Tully of ChatOwl Welcome to Health-e Law, Sheppard Mullin's podcast addressing the fascinating health-tech topics and trends of the day. Our digital health legal team, alongside brilliant experts and thought-leaders, share how innovations can solve some of healthcare’s (and maybe the world’s) biggest problems, if properly navigated. In our inaugural episode, Dr. Laura Tully, Vice President of Clinical Services at ChatOwl, a virtual mental wellness company, joins our hosts to discuss the importance of transparency in health-tech’s data collection and use, including how it can drive engagement and outcome. What We Discussed in this Episode What have you been working on? Why is data your world right now? What kind of solutions and digital health products trigger issues related to data collection and use? Why is the healthcare industry so ravenous for data on both the solutions and business sides? What does retention look like? How can transparency boost those numbers? Can a greater level of transparency enhance the quality of the data that's collected? What does transparency look like in practice? About Dr. Laura Tully is a Harvard-trained, internationally-recognized subject matter expert in digital health solutions for serious mental health. Her specific expertise includes ethical data use, trauma-informed suicide risk management, and digital wellness products for marginalized communities. As ChatOwl, Inc.'s Vice President of Clinical Services, she spearheads the development of AI-driven clinical interventions accessible to all adults facing mental health challenges. Before joining ChatOwl, Dr. Tully served UC Davis Health, first as Director of Clinical Training in Early Psychosis Programs, then as Assistant Director of the California Early Psychosis Training and Technical Assistance Program (EP TTA), and finally as Associate Professor in Psychiatry. Since joining ChatOwl, she has maintained an association with UC Davis as an Adjunct Associate Professor in the School of Medicine. About Sara Shanti A partner in the Corporate Practice Group in the Sheppard Mullin's Chicago office and co-lead of its Digital Health Team, practice sits at the forefront of healthcare technology by providing practical counsel on novel innovation and complex data privacy matters. Using her medical research background and HHS experience, Sara advises providers, payors, start-ups, technology companies, and their investors and stakeholders on digital healthcare and regulatory compliance matters, including artificial intelligence (AI), augmented and virtual reality (AR/VR), gamification, implantable and wearable devices, and telehealth. At the cutting-edge of advising on "data as an asset" programming, Sara's practice supports investment in innovation and access to care initiatives, including mergers and acquisitions involving crucial, high-stakes and sensitive data, medical and wellness devices, and web-based applications and care. About Phil Kim A partner in the Corporate and Securities Practice Group in Sheppard Mullin's Dallas office and co-lead of its Digital Health Team, has a number of clients in digital health. He has assisted multinational technology companies entering the digital health space with various service and collaboration agreements for their wearable technology, along with global digital health companies bolstering their platform in the behavioral health space. He also assists public medical device, biotechnology, and pharmaceutical companies, as well as the investment banks that serve as underwriters in public securities offerings for those companies. Phil also assists various healthcare companies on transactional and regulatory matters. He counsels healthcare systems, hospitals, ambulatory surgery centers, physician groups, home health providers, and other healthcare companies on the buy- and sell-side of mergers and acquisitions, joint ventures, and operational matters, which include regulatory, licensure, contractual, and administrative issues. Phil regularly advises clients on matters related to healthcare compliance, including liability exposure, the Stark law, anti-kickback statutes, and HIPAA/HITECH privacy issues. He also provides counsel on state and federal laws, business structuring formation, employment issues, and involving government agencies, including state and federal agencies. Contact Info: Additional Resources: Thank you for listening! Don't forget to SUBSCRIBE to the show to receive new episodes delivered straight to your podcast player every month. If you enjoyed this episode, please help us get the word out about this podcast. Rate and Review this show on , , , or . It helps other listeners find this show. This podcast is for informational and educational purposes only. It is not to be construed as legal advice specific to your circumstances. If you need help with any legal matter, be sure to consult with an attorney regarding your specific needs. /episode/index/show/d148bbc4-cc5a-41b1-8595-41e12e629d0e/id/28966193

Health-e Law Trailer 11/30/2023

Health-e Law Trailer Hosts Phil Kim and Sara Shanti introduce Health-e Law, a new podcast produced by Sheppard Mullin’s Digital Health Team focusing on the exciting and sometimes explosive interaction between technology and law in the healthcare space. Join our hosts as they engage with industry innovators and thought leaders, exploring AI, virtual reality, and other emerging technologies poised to reshape healthcare as we know it. They’ll also dissect recent regulatory and legislative efforts in the health and wellness arena while hopefully having a bit of fun along the way! If you’re struggling to stay on top of the rapidly evolving landscape that is healthcare tech, these brief, bite-sized episodes, will keep you in the know. About Sara Shanti A partner in the Corporate Practice Group in the Sheppard Mullin’s Chicago office, practice sits at the forefront of health-technology by providing practical counsel on healthcare innovation and complex data privacy matters. Using her medical research background and HHS experience, Sara advises providers, payors, start-ups, technology companies, and their investors and stakeholders on digital and novel healthcare regulatory compliance matters, including artificial intelligence and machine learning (AI/ML), augmented and virtual reality (AR/VR), data assets and privacy, gamification, implantable and wearable devices, and telehealth. Sara has deep experience advising clients on data use and protection under Part 2, HIPAA, GINA, and state privacy laws, such as BIPA and CCPA, and multinational border transmissions. She also assists clients in implementing compliance programs, launching health innovations and investments, and responding to governmental investigations. Her experience extends to consumer and patient rights, including under the American Disabilities Act and Section 1557, medical staff relationships, and navigating the evolving regulatory landscapes for next-generation technology. She also has extensive experience navigating telehealth prescribing laws, including the Ryan Haight Act, and with entities offering services in sensitive healthcare areas, such as behavioral health, fertility, genetics, and substance abuse. At the cutting-edge of advising on “data as an asset” programming, red team technology reviews, and information blocking and interoperability under the 21st Century Cures Act, Sara’s practice also includes mergers and acquisitions involving crucial, high-stakes, and sensitive data in areas of digital health platforms, medical and wellness devices, and web-based applications and treatment. About Phil Kim A Partner in the Corporate and Securities Practice Group in Sheppard Mullin’s Dallas office, advises various types of healthcare providers in connection with transactional and regulatory matters. He counsels healthcare systems, hospitals, ambulatory surgery centers, physician groups (including non-profit health organizations, or NPHOs), home health providers, and other healthcare companies on the buy- and sell-side of mergers and acquisitions, joint ventures, and operational matters, which include regulatory, licensure, contractual, and administrative issues. Phil has a particular interest in digital health. He has assisted a number of multinational technology companies entering the digital health space with various service and collaboration agreements for their wearable technology. He also assists public medical device, biotechnology, and pharmaceutical companies, as well as the investment banks that serve as underwriters involved in the public securities offerings for such healthcare companies. Phil regularly advises clients on matters related to healthcare compliance, including liability exposure, the Stark law, anti-kickback statutes, and HIPAA/HITECH privacy issues. He also provides counsel on state and federal laws, business structuring formation, employment issues, and involving government agencies, including various state Medicaid agencies, the Texas Medical Board, and Medicare Administrative Contractors. Contact Info: Thank you for listening! Don't forget to SUBSCRIBE to the show to receive new episodes delivered straight to your podcast player every month. If you enjoyed this episode, please help us get the word out about this podcast. Rate and Review this show on , , , or . It helps other listeners find this show. This podcast is for informational and educational purposes only. It is not to be construed as legal advice specific to your circumstances. If you need help with any legal matter, be sure to consult with an attorney regarding your specific needs. /episode/index/show/d148bbc4-cc5a-41b1-8595-41e12e629d0e/id/28851533

Sheppard Mullin's Health-e Law

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