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

    AI in Clinical Research: Opportunities, Risks, and the Road Ahead with Bill Kish and Dr. Brad Pruitt of Kenosha AI
    2025/07/24
    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 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 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, 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 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 Bill Kish Dr. Brad Pruitt Sara Shanti Additional Resources Kenosha AI - 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 ...
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    14 分
  • Navigating AI: Governance and Innovation at UCSD Health with Ron Skillens of UCSD Health

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

    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

    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

    Ron Skillens

    Michael Orlando

    Additional Resources

    AI Governance Checklist

    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.
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    17 分
  • Crossroads of Care: Navigating Executive Orders with Jonathan Meyer, former DHS GC and Partner at Sheppard Mullin

    Crossroads of Care: Navigating Executive Orders with Jonathan Meyer, former DHS GC and Partner at Sheppard Mullin
    2025/02/25
    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, Jonathan E. Meyer 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, 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 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 Jonathan E. Meyer Sara Shanti Additional Resources Trump Executives Action Tracker 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.
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    9 分
  • Healthcare Security is Homeland Security with Jonathan Meyer, former DHS GC and Partner at Sheppard Mullin

    Healthcare Security is Homeland Security with Jonathan Meyer, former DHS GC and Partner at Sheppard Mullin
    2025/02/05
    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, Jonathan E. Meyer 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, 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 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 Jonathan E. Meyer 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.
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    13 分
  • The Future (of Healthcare) is Female with Danielle Vrabie and Amanda Zablocki, Co-Chairs of Sheppard Mullin’s WHLC

    The Future (of Healthcare) is Female with Danielle Vrabie and Amanda Zablocki, Co-Chairs of Sheppard Mullin’s WHLC
    2024/12/06
    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 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, Amanda Zablocki 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, 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...
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    17 分
  • Overcoming Challenges to Innovation in Preventative Care with Steven Collens of MATTER

    Overcoming Challenges to Innovation in Preventative Care with Steven Collens of MATTER
    2024/10/10
    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 MATTER, 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 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 HugeDomains.com 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, 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 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, Phil Kim 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 Sara Shanti’s Phil Kim Steven Collens Resources MATTER 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. ...
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    17 分
  • Healthcare Needs More Hackers with Ilona Cohen of HackerOne

    Healthcare Needs More Hackers with Ilona Cohen of HackerOne
    2024/09/26
    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 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, 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 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, Phil Kim 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, Michael D. 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 ...
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    16 分
  • CURES and Beyond: Reining in the Long Tail of Healthcare with Gregory Stein of Shadowbox

    CURES and Beyond: Reining in the Long Tail of Healthcare with Gregory Stein of Shadowbox
    2024/07/18
    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 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, 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 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, Phil Kim 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 Gregory A. Stein Sara Shanti Phil Kim Resources Shadowbox 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 ...
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    16 分