Digital Health in the Metaverse: Navigating the Interplay Between Healthcare Delivery and Healthcare Laws
Licensing, Data Privacy and Security, Fraud and Abuse, and Interoperability Compliance
Recording of a 90-minute CLE video webinar with Q&A
This CLE course will guide participants on digital health regulatory issues and how they are implicated in the metaverse. The panel will discuss the regulation of digital health products and services, data privacy and security, fraud and abuse, and interoperability issues in the United States. The panel will address issues from diagnosing to treating and ongoing patient management. The panel will discuss what steps counsel can take to mitigate those risks.
Outline
- Digital health in the metaverse
- Diagnostics
- Treatment
- Medical education and research
- Patient management
- Collaborative relationships
- Regulation of digital health products/services
- Healthcare services and licensing
- FDA regulation (e.g. software as a medical device)
- Reimbursement standards
- Interoperability
- Standards and design
- 21st Century Cures Act
- Data privacy and security
- HIPAA and FTC
- State laws
- FDA cybersecurity
- Fraud and abuse
- Self-referral prohibitions (e.g. Stark Law)
- Anti-Kickback laws
- False claims
- Mitigating risks and ensuring compliance
Benefits
The panel will review these and other vital issues:
- What are the major regulatory considerations for companies entering the digital health metaverse?
- What steps should counsel take to mitigate the risk of violating healthcare laws in the metaverse?
Faculty
Lara D. Compton
Member
Mintz Levin Cohn Ferris Glovsky and Popeo
Ms. Compton is a trusted advisor to clients ranging from traditional health care providers to disrupter digital health... | Read More
Ms. Compton is a trusted advisor to clients ranging from traditional health care providers to disrupter digital health platforms as they navigate the practical and regulatory challenges of health care innovation. She counsels telemedicine and other digital health clients on business plan strategy and implementation, state-specific telemedicine regulation, corporate practice of medicine, the scope of practice, fee splitting, anti-kickback, reimbursement, and other health care regulatory issues. Leveraging her prior in-house experience at two nonprofit health systems, Ms. Compton also advises health care providers on the incorporation of telehealth and other technology infrastructures, which has seen a vast uptick as a result of the COVID-19 pandemic. She advises health care providers, clinical trials companies, ancillary providers, technology start-ups, HMOs, insurance companies, and large technology companies on HIPAA and other health data privacy and security regulations, including developing and implementing HIPAA compliance programs. She has also led significant HIPAA breach investigations, advising clients on risk management and mitigation efforts.Member
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Rick L. Hindmand
Counsel
McDonald Hopkins
Mr. Hindman focuses his practice on healthcare regulatory, data privacy, cybersecurity, corporate, and... | Read More
Mr. Hindman focuses his practice on healthcare regulatory, data privacy, cybersecurity, corporate, and transactional matters. He represents physicians and other healthcare providers and organizations in structuring group practices, joint ventures, medical device companies, as well as physician/hospital alignment strategies and involvement in accountable care organizations (ACOs). He also assits healthcare providers and businesses with potential compliance challenges, including compliance with the Stark physician self-referral law, federal and state anti-kickback laws, and corporate practice and fee-splitting restrictions.
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Benjamin M. Zegarelli, Esq.
Of Counsel
Mintz Levin Cohn Ferris Glovsky and Popeo
Mr. Zegarelli provides counsel on compliance and regulatory issues to clients in the pharmaceutical, medical device,... | Read More
Mr. Zegarelli provides counsel on compliance and regulatory issues to clients in the pharmaceutical, medical device, and biotech industries. He advises health care industry clients on the federal and state laws surrounding manufacturer product development and marketing. He has experience representing medical device companies in responding to significant unfavorable inspection observations, and he participates in the coordination of diligence reviews of transactions involving large pharmaceutical and medical device manufactures. He also reviews and drafts clinical study agreements for clients.
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