• The Future (of Healthcare) is Female with Danielle Vrabie and Amanda Zablocki, Co-Chairs of Sheppard Mullin’s WHLC
    Dec 6 2024
    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 mins
  • Overcoming Challenges to Innovation in Preventative Care with Steven Collens of MATTER
    Oct 10 2024
    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 mins
  • Healthcare Needs More Hackers with Ilona Cohen of HackerOne
    Sep 26 2024
    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 mins
  • CURES and Beyond: Reining in the Long Tail of Healthcare with Gregory Stein of Shadowbox
    Jul 18 2024
    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 mins
  • Assessing Data Assets in Healthcare with Arti Bedi Pullins of QuestionPro
    Jun 27 2024
    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 Arti Bedi 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, 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 Arti Bedi Pullins Sara Shanti Phil Kim 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 ...
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    16 mins
  • Remote Patient Monitoring Innovating Health Tech with Dr. Vipul Kella of Physio AI
    May 2 2024
    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, Dr. Vipul Kella 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, 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 Vipul Kella Sara Shanti Phil Kim 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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    15 mins
  • What We Heard at HIMSS 2024 with Michael Orlando & Carolyn Metnick
    Apr 18 2024
    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 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 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, 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 Information Carolyn Metnick Michael Orlando Phil Kim 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 ...
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    15 mins
  • Health Vibes at ViVE with Sara Shanti and Carolyn Metnick
    Mar 21 2024
    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 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, 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 Information Carolyn Metnick Sara Shanti Phil Kim 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 ...
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    11 mins