Sheppard's Health-e Law

Welcome to Health-e Law, Sheppard's podcast exploring the fascinating health tech topics and trends of the day. In this episode, partner and host Sara Shanti sits down with Erik Pupo, Director of Commercial Health IT at Guidehouse, to discuss how healthcare's push toward greater connectivity and data sharing creates new cybersecurity risks, and what health systems need to do to stay ahead of emerging threats. What we discuss in this episode: The current cybersecurity landscape for hospitals and health systems What TEFCA is and why it matters for healthcare data sharing The core cybersecurity practices providers of all sizes should have in place Cautionary tales from the field that emphasize the importance of maintaining a strong cybersecurity program About Erik Pupo Erik Pupo has spent more than 25 years advising healthcare organizations on technology, cybersecurity and business transformation. As Director of Commercial Health IT Advisory at Guidehouse, he helps healthcare organizations modernize their IT infrastructure as a principal strategist in cloud, security, data and AI. Prior to joining Guidehouse, Erik served as Global Principal Practice Manager for Healthcare Cybersecurity at Amazon Web Services, helping health systems navigate the security challenges of moving critical infrastructure to the cloud. Before that, he served as Chief Information Officer at Columbia University Irving Medical Center, leading IT strategy and operations for one of the nation's most complex academic medical environments. Earlier in his career, Erik spent nearly a decade in global consulting, first as Senior Manager at Deloitte, where he led health IT initiatives for the Office of the National Coordinator for Health IT, the Department of Defense, and the Department of Veterans Affairs. He later served as Managing Director at Accenture, where he led strategic and technological transformation initiatives for providers, payers, and life sciences companies across North America. About Sara Shanti A partner in the Corporate practice group in Sheppard's Chicago office, and co-lead of the firm's Digital Health team, Sara Shanti's 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 also 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 Erik Pupo Sara Shanti 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 Apple Podcasts, Amazon Music, or Spotify. 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.

Welcome to Health-e Law, Sheppard's podcast exploring the fascinating health tech topics and trends of the day. In the second part of this two-part episode, Cora Han, Chief Health Data Officer for University of California Health, joins partner and host Michael Orlando to discuss the current state of AI adoption across healthcare systems, including deployment, governance challenges, regulatory developments and the future of AI-enabled care delivery. What we discuss in this episode: The growing role and current state of AI adoption across healthcare delivery systems Ambient scribes, inbox management, coding assistance and other practical AI use cases Using AI to improve quality reporting and operational efficiency Opportunities for AI to address clinician shortages, burnout and healthcare access issues Expanding access to specialized care through AI-enabled care models The challenges of evaluating and governing a rapidly growing AI vendor ecosystem Adapting governance frameworks to keep pace with AI innovation Federal and state regulatory developments impacting healthcare AI adoption The importance of transparency in AI tools, including model development, performance and use Why implementation and workflow integration remain critical barriers to successful AI adoption Measuring ROI and real-world impact of AI tools in healthcare settings About Cora Han Cora Han is Chief Health Data Officer for University of California Health and Executive Director of the Center for Data-driven Insights and Innovation. She also serves as Co-Chair of the Health System and Provider Advisory Board for the Coalition for Health AI (CHAI). Drawing on her extensive experience in AI strategy, regulatory advocacy, and data privacy, Cora leads efforts to establish consistent guardrails for the use of health data with AI vendors and third-party collaborators. Her work spans the full spectrum of health data challenges, from de-identification of clinical data to navigating HIPAA compliance and AI vendor relationships, making her a leading voice on responsible AI adoption in academic health systems. Before joining UC Health, Cora spent over ten years at the Federal Trade Commission, most recently as Senior Attorney in the Division of Privacy and Identity Protection, where she focused on data privacy and consumer protection, including a term as Counsel to the Director of the Bureau of Consumer Protection. Prior to her tenure at the FTC, she practiced at a leading international law firm, where she counseled clients on copyright and trademark matters. Cora also served as an Adjunct Professor of Consumer Protection Law at George Mason University School of Law for five years. Cora holds a BA in Government from Harvard University and a JD from the University of Chicago Law School. About Michael Orlando Michael Orlando is a partner in Sheppard's San Diego (Del Mar) office. He is team leader of the firm's Technology Transactions team, a member of the Life Sciences, Healthcare and Artificial Intelligence teams, and co-leader of the firm's Digital Health & Innovation team. Michael has more than 20 years of experience advising health technology companies, insurers, healthcare systems and providers, academic medical centers and research institutions, medical device manufacturers, pharmaceutical and wellness companies on intellectual property and business transactions in key strategic areas, including EHR systems procurement and integration, telehealth, mobile health applications, clinical decision support technologies, artificial intelligence, data use, wearable devices, remote patient monitoring, medical devices and equipment, research and collaborations, patent licenses, software licenses, joint ventures, mergers and acquisitions, revenue cycle management, and other outsourcing transactions. Michael founded a software-as-a-service company before entering private practice and completed an in-house secondment at a publicly traded biotechnology company, an experience that informs his practical and business-focused approach to client engagements. 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 Apple Podcasts, Amazon Music, or Spotify. 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.

Welcome to Health-e Law, Sheppard's podcast exploring the fascinating health tech topics and trends of the day. In part one of this two-part episode, Cora Han, Chief Health Data Officer for University of California Health, joins partner and host Michael Orlando to discuss the adoption of Artificial Intelligence in healthcare, including the management of data privacy, vendor relationships and AI governance. What we discuss in this episode: De-identification of protected health information in practice The HIPAA standards for de-identification and when to apply them The unique challenges unstructured clinical notes present for re-identification risk A layered approach to de-identification, including automated tools and human review Third-party certification of de-identification processes Key contract provisions for protecting PHI when working with AI vendors Hidden data training clauses in vendor agreements The evolving AI vendor marketplace and contract strategy UC Health's federated governance model for AI and data governance Shadow AI use and the importance of safe experimentation The importance of legal and compliance teams engaging early in the AI adoption process About Cora Han Cora Han is Chief Health Data Officer for University of California Health and Executive Director of the Center for Data-driven Insights and Innovation. She also serves as Co-Chair of the Health System and Provider Advisory Board for the Coalition for Health AI (CHAI). Drawing on her extensive experience in AI strategy, regulatory advocacy, and data privacy, Cora leads efforts to establish consistent guardrails for the use of health data with AI vendors and third-party collaborators. Her work spans the full spectrum of health data challenges, from de-identification of clinical data to navigating HIPAA compliance and AI vendor relationships, making her a leading voice on responsible AI adoption in academic health systems. Before joining UC Health, Cora spent over ten years at the Federal Trade Commission, most recently as Senior Attorney in the Division of Privacy and Identity Protection, where she focused on data privacy and consumer protection, including a term as Counsel to the Director of the Bureau of Consumer Protection. Prior to her tenure at the FTC, she practiced at a leading international law firm, where she counseled clients on copyright and trademark matters. Cora also served as an Adjunct Professor of Consumer Protection Law at George Mason University School of Law for five years. Cora holds a BA in Government from Harvard University and a JD from the University of Chicago Law School. About Michael Orlando Michael Orlando is a partner in Sheppard's San Diego (Del Mar) office. He is team leader of the firm's Technology Transactions team, a member of the Life Sciences, Healthcare and Artificial Intelligence teams, and co-leader of the firm's Digital Health & Innovation team. Michael has more than 20 years of experience advising health technology companies, insurers, healthcare systems and providers, academic medical centers and research institutions, medical device manufacturers, pharmaceutical and wellness companies on intellectual property and business transactions in key strategic areas, including EHR systems procurement and integration, telehealth, mobile health applications, clinical decision support technologies, artificial intelligence, data use, wearable devices, remote patient monitoring, medical devices and equipment, research and collaborations, patent licenses, software licenses, joint ventures, mergers and acquisitions, revenue cycle management, and other outsourcing transactions. Michael founded a software-as-a-service company before entering private practice and completed an in-house secondment at a publicly traded biotechnology company, an experience that informs his practical and business-focused approach to client engagements. 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 Apple Podcasts, Amazon Music, or Spotify. 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.

Welcome to Health-e Law, Sheppard's podcast exploring the fascinating health tech topics and trends of the day. In this episode, Ernie Ianace, founder and CEO of CareAlly, joins partner and host Michael Orlando to explain how AI orchestration can allow skilled nursing facilities to automate complex workflows, while keeping humans in the loop for clinical and regulatory decisions. What we discuss in this episode: What CareAlly is, and the day-to-day issues it addresses for skilled nursing facilities How executives should approach choosing the first workflow to automate in a modular AI architecture What makes a good starting point to quickly demonstrate value without threatening existing staff What human-in-the-loop looks like in practice for operators, clinicians and compliance teams How the implementation differs in the skilled nursing environment compared to other healthcare settings How real-time data sharing changes care management, denial prevention and outcomes in these value-based arrangements How to avoid AI sprawl of various disconnected, independent systems Upcoming Webinar Register now for our April 23 webinar: AI for SNFs: A Roadmap for Reducing Costs, Improving Care and Gaining a Competitive Advantage. About Ernie Ianace Ernie Ianace is the CEO of CareAlly, an AI orchestration platform purpose-built to address healthcare's most urgent operational challenges: workforce shortages and care coordination breakdowns. A founder and growth-focused executive with more than two decades of experience, Ernie has built and scaled technology companies across healthcare, senior living, cybersecurity, IoT, and AI. Throughout his career, he has led global commercial teams, launched new markets, and forged strategic partnerships that have collectively generated over $3 billion in exit value. In addition to his role at CareAlly, Ernie serves as Chief Commercial Officer of InsightAlly.ai, the parent company behind a versatile AI orchestration engine serving healthcare, government, education, and enterprise productivity sectors. In this role, he drives strategic commercialization and market expansion, helping organizations streamline complex workflows and reduce operational friction at scale. About Michael Orlando Michael Orlando is a partner in Sheppard's San Diego (Del Mar) office. He is team leader of the firm's Technology Transactions team, a member of the Life Sciences, Healthcare and Artificial Intelligence teams, and co-leader of the firm's Digital Health & Innovation team. Michael has more than 20 years of experience advising health technology companies, insurers, healthcare systems and providers, academic medical centers and research institutions, medical device manufacturers, pharmaceutical and wellness companies on intellectual property and business transactions in key strategic areas, including EHR systems procurement and integration, telehealth, mobile health applications, clinical decision support technologies, artificial intelligence, data use, wearable devices, remote patient monitoring, medical devices and equipment, research and collaborations, patent licenses, software licenses, joint ventures, mergers and acquisitions, revenue cycle management, and other outsourcing transactions. Michael founded a software-as-a-service company before entering private practice and completed an in-house secondment at a publicly traded biotechnology company, an experience that informs his practical and business-focused approach to client engagements. Resources: CareAlly 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 Apple Podcasts, Amazon Music, or Spotify. 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.

Welcome to Health-e Law, Sheppard's podcast exploring the fascinating health tech topics and trends of the day. In this episode, Sheppard partner and host Michael Orlando is joined by associate Michael Sutton to discuss their experience at ViVE 2026, the premier conference for digital health innovators and leaders. What we discuss in this episode: The current prevalence and role of AI in healthcare How limited interoperability of legacy systems hinders AI adoption How AI has changed the way data is treated Potential healthcare use cases for agentic AI Challenges when using AI in the healthcare setting Why the concept of a "Human-in-the-Loop" is particularly important in healthcare The quality metrics providers should measure when evaluating AI The factors that ultimately determine whether an AI tool succeeds or fails in healthcare settings About Michael Sutton An associate in the Corporate practice group at Sheppard's Dallas office, Michael Sutton 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. About Michael Orlando Michael Orlando is a partner in Sheppard's San Diego (Del Mar) office. He is team leader of the firm's Technology Transactions team, a member of the Life Sciences, Healthcare and Artificial Intelligence teams, and co-leader of the firm's Digital Health & Innovation team. Michael has more than 20 years of experience advising health technology companies, insurers, healthcare systems and providers, academic medical centers and research institutions, medical device manufacturers, pharmaceutical and wellness companies on intellectual property and business transactions in key strategic areas, including EHR systems procurement and integration, telehealth, mobile health applications, clinical decision support technologies, artificial intelligence, data use, wearable devices, remote patient monitoring, medical devices and equipment, research and collaborations, patent licenses, software licenses, joint ventures, mergers and acquisitions, revenue cycle management, and other outsourcing transactions. Michael founded a software-as-a-service company before entering private practice and completed an in-house secondment at a publicly traded biotechnology company, an experience that informs his practical and business-focused approach to client engagements. Resources: ViVE 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 Apple Podcasts, Amazon Music, or Spotify. 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.