Sheppard Mullin's Health-e Law – Details, episodes & analysis

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. 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 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 de-identification.

Michael has managed investigations, worked to resolve active breach incidents, and advised clients on healthcare privacy and technology matters. He supports clients navigating HIPAA and other privacy laws to ensure their objectives are achieved within all legal and regulatory requirements. Michael also provides comprehensive regulatory services to a range of healthcare participants, including investors, managed care organizations, health plans, and medical groups.  In particular, he has tackled operational and contractual negotiations, licensing, compliance, and fraud considerations and conducted regulatory due diligence for transactions, including mergers and acquisitions.

Michael also supports transactions involving tech companies and healthcare providers, guiding negotiations related to software and service relationships while identifying vulnerabilities in targets and devising creative solutions to address them.

Contact Info

Ilona Cohen

Sara Shanti

Phil Kim

Michael D. Sutton 

Resources

HackerOne

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 Mullin's podcast addressing the fascinating health-tech topics and trends of the day. Our digital health legal team, alongside brilliant experts and thought leaders, share how innovations can solve some of healthcare’s (and maybe the world’s) biggest problems, if properly navigated. In this episode, Viveka Rydell-Anderson, CEO of Pacific Vision Foundation, joins us to discuss the critical need for specialized care and how emerging digital technologies can help overcome access challenges.

What We Discussed In This Episode

• What specifically is specialized care?

• How is new and emerging technology transforming specialized care?

• Where are we today in terms of access?

• How can the industry transition from “sick care” to “healthcare”? 

• Do you see patients embracing this technology?

• What do developers need to consider as they seek to meet patients' needs?

• What are you hearing from providers? What do they want from technology?

• What technologies, including in FemTech, do you see as poised to make a difference and mitigate stigmas?

• From a lawyer's perspective, how do you see businesses having to adapt and navigate what's ahead of them?

About Viveka Rydell-Anderson

With over 20 years of experience as a lawyer, healthcare executive and innovator, Viveka Rydell-Anderson is a passionate trailblazer in the realm of healthcare equity and access.

Viveka is the CEO of Pacific Vision Foundation and the president of the HIMSS Northern California Chapter. She has deep experience in FemTech and specialized care spaces, among her many other impressive achievements, including holding a Master of Science in Clinical Informatics Management from Stanford University School of Medicine in addition to her law degree from UC Berkeley.

Before taking on her current role, Viveka spent 14 years as CEO of PDI Surgery Center, a nonprofit Ambulatory Surgery Center providing specialty dental care to children and special needs patients in 30+ California counties. She then co-founded two MedTech startups: ImageChain.ai and Mamsen Health. 

About Sara Shanti

A partner in the Corporate Practice Group in the Sheppard Mullin's Chicago office and co-lead of its Digital Health Team, Sara’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:

Viveka Rydell-Anderson 

Sara Shanti

Phil Kim

Digital Health Attorneys | Sheppard Mullin

Additional Resources

Pacific Vision Foundation

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, Google 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 Mullin's podcast addressing the fascinating health-tech topics and trends of the day. Our digital health legal team, alongside brilliant experts and thought-leaders, share how innovations can solve some of healthcare’s (and maybe the world’s) biggest problems, if properly navigated. 

In this episode, Sheppard Mullin partner Jim Gatto, co-chair of its AI Team, joins us to discuss the AI revolution in healthcare, including how it is enhancing and improving the industry while navigating ethical and legal risks. 

What We Discussed In This Episode

• How is AI impacting healthcare today?

• Why are we seeing an explosion of AI, especially in healthcare, now?

• Looking forward, where are you seeing AI growing in applications? 

• How will AI impact and improve access to care, particularly in terms of elder care and the epidemic of isolation?

• What are some of the most significant risks or legal issues that arise from the confluence of AI and healthcare?

About James G. Gatto

James G. Gatto is a partner in the Intellectual Property Practice Group in Sheppard Mullin’s Washington, D.C. office, where he also serves as Co-Leader of the firm’s Artificial Intelligence Team and Leader of the Open Source Team.

Jim’s practice focuses on AI, blockchain, interactive entertainment and open source. He provides strategic advice on all aspects of intellectual property strategy and enforcement, technology transactions, licenses, and tech-related regulatory issues, especially ones driven by new business models and/or disruptive technologies. Jim has over two decades of experience advising clients on AI issues and is an adjunct professor who teaches a course on Artificial Intelligence Legal Issues. He is considered a thought-leader on legal issues associated with emerging technologies and business models, most recently blockchain, AI, open source, and interactive entertainment. 

About Sara Shanti

A partner in the Corporate Practice Group in the Sheppard Mullin's Chicago office and co-lead of its Digital Health Team, Sara’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:

James G. Gatto

Sara Shanti

Phil Kim

Additional Resources

Jobs of Tomorrow: Large Language Models and Jobs

5 Things Corporate Boards Should Know About Generative AI Risk Management

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, Google 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 Mullin's podcast addressing the fascinating health-tech topics and trends of the day. Our digital health legal team, alongside brilliant experts and thought-leaders, share how innovations can solve some of healthcare’s (and maybe the world’s) biggest problems, if properly navigated.

In our inaugural episode, Dr. Laura Tully, Vice President of Clinical Services at ChatOwl, a virtual mental wellness company, joins our hosts to discuss the importance of transparency in health-tech’s data collection and use, including how it can drive engagement and outcome.

What We Discussed in this Episode

• What have you been working on? Why is data your world right now?

• What kind of solutions and digital health products trigger issues related to data collection and use?

• Why is the healthcare industry so ravenous for data on both the solutions and business sides?

• What does retention look like? How can transparency boost those numbers?

• Can a greater level of transparency enhance the quality of the data that's collected?

• What does transparency look like in practice?

About Dr. Laura Tully

Dr. Laura Tully is a Harvard-trained, internationally-recognized subject matter expert in digital health solutions for serious mental health. Her specific expertise includes ethical data use, trauma-informed suicide risk management, and digital wellness products for marginalized communities. As ChatOwl, Inc.'s Vice President of Clinical Services, she spearheads the development of AI-driven clinical interventions accessible to all adults facing mental health challenges. 

Before joining ChatOwl, Dr. Tully served UC Davis Health, first as Director of Clinical Training in Early Psychosis Programs, then as Assistant Director of the California Early Psychosis Training and Technical Assistance Program (EP TTA), and finally as Associate Professor in Psychiatry. Since joining ChatOwl, she has maintained an association with UC Davis as an Adjunct Associate Professor in the School of Medicine.

About Sara Shanti

A partner in the Corporate Practice Group in the Sheppard Mullin's Chicago office and co-lead of its Digital Health Team, Sara’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:

Dr. Laura Tully

Sara Shanti

Phil Kim

Additional Resources:

National Institute of Mental Health – Statistics on Mental Illness

National Library of Medicine – User Experience, Engagement, and Popularity in Mental Health Apps

Objective User Engagement with Mental Health Apps – System Search and Panel-Based Usage Analysis 

Incorporating Community Partner Perspectives on eHealth Technology Data Sharing Practices for the California Early Psychosis Intervention Network: Qualitative Focus Group Study With a User-Centered Design Approach

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, Google 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.

Hosts Phil Kim and Sara Shanti introduce Health-e Law, a new podcast produced by Sheppard Mullin’s Digital Health Team focusing on the exciting and sometimes explosive interaction between technology and law in the healthcare space. Join our hosts as they engage with industry innovators and thought leaders, exploring AI, virtual reality, and other emerging technologies poised to reshape healthcare as we know it. They’ll also dissect recent regulatory and legislative efforts in the health and wellness arena while hopefully having a bit of fun along the way! If you’re struggling to stay on top of the rapidly evolving landscape that is healthcare tech, these brief, bite-sized episodes, will keep you in the know.

About Sara Shanti

A partner in the Corporate Practice Group in the Sheppard Mullin’s Chicago office, Sara Shanti’s practice sits at the forefront of health-technology by providing practical counsel on healthcare innovation and complex data privacy matters. Using her medical research background and HHS experience, Sara advises providers, payors, start-ups, technology companies, and their investors and stakeholders on digital and novel healthcare regulatory compliance matters, including artificial intelligence and machine learning (AI/ML), augmented and virtual reality (AR/VR), data assets and privacy, gamification, implantable and wearable devices, and telehealth.

Sara has deep experience advising clients on data use and protection under Part 2, HIPAA, GINA, and state privacy laws, such as BIPA and CCPA, and multinational border transmissions. She also assists clients in implementing compliance programs, launching health innovations and investments, and responding to governmental investigations. Her experience extends to consumer and patient rights, including under the American Disabilities Act and Section 1557, medical staff relationships, and navigating the evolving regulatory landscapes for next-generation technology. She also has extensive experience navigating telehealth prescribing laws, including the Ryan Haight Act, and with entities offering services in sensitive healthcare areas, such as behavioral health, fertility, genetics, and substance abuse.

At the cutting-edge of advising on “data as an asset” programming, red team technology reviews, and information blocking and interoperability under the 21st Century Cures Act, Sara’s practice also includes mergers and acquisitions involving crucial, high-stakes, and sensitive data in areas of digital health platforms, medical and wellness devices, and web-based applications and treatment.

About Phil Kim

A Partner in the Corporate and Securities Practice Group in Sheppard Mullin’s Dallas office, Phil Kim advises various types of healthcare providers in connection with transactional and regulatory matters. He counsels healthcare systems, hospitals, ambulatory surgery centers, physician groups (including non-profit health organizations, or NPHOs), home health providers, and other healthcare companies on the buy- and sell-side of mergers and acquisitions, joint ventures, and operational matters, which include regulatory, licensure, contractual, and administrative issues.

Phil has a particular interest in digital health. He has assisted a number of multinational technology companies entering the digital health space with various service and collaboration agreements for their wearable technology. He also assists public medical device, biotechnology, and pharmaceutical companies, as well as the investment banks that serve as underwriters involved in the public securities offerings for such healthcare companies.

Phil regularly advises clients on matters related to healthcare compliance, including liability exposure, the Stark law, anti-kickback statutes, and HIPAA/HITECH privacy issues. He also provides counsel on state and federal laws, business structuring formation, employment issues, and involving government agencies, including various state Medicaid agencies, the Texas Medical Board, and Medicare Administrative Contractors.

Contact Info:

Sara Shanti

Phil Kim

Digital Health Attorneys | Sheppard Mullin

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, Google 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 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 need help with any legal matter, be sure to consult with an attorney regarding your specific needs.

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 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 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.

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 specific to your circumstances. If you need help with any legal matter, be sure to consult with an attorney regarding your specific needs.