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

A live 90-minute CLE video webinar with interactive Q&A

This program is included with the Strafford CLE Pass. Click for more information.
This program is included with the Strafford All-Access Pass. Click for more information.

Wednesday, August 17, 2022 (Tomorrow)

1:00pm-2:30pm EDT, 10:00am-11:30am PDT

or call 1-800-926-7926
Course Materials

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.

Description

The metaverse is shared interactive and collaborative (e.g., virtual 3D and augmented reality) worlds where people can work and play. Like many other industries, healthcare has begun to expand its metaverse presence as the metaverse grows. Potential healthcare applications include diagnosis and treatment (e.g., virtual health clinics and digital therapeutics), drug interaction evaluation, ongoing patient management, and more.

Among the issues that players in the digital health metaverse need to consider is compliance with healthcare laws and regulations. Healthcare services and products tend to be heavily regulated. Data privacy and security requirements (e.g. HIPAA) are of concern in the metaverse as they are in the real world. Stark Law, Anti-Kickback Statute, and the False Claims Act should also be considered when providing healthcare services in the metaverse.

Listen as our authoritative panel of healthcare attorneys discusses digital health issues in the metaverse. The panel will discuss regulatory regimes that apply to metaverse digital health services and products, data privacy and security, interoperability, and fraud and abuse issues. 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.

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Outline

  1. Digital health in the metaverse
    1. Diagnostics
    2. Treatment
    3. Medical education and research
    4. Patient management
    5. Collaborative relationships
  2. Regulation of digital health products/services
    1. Healthcare services and licensing
    2. FDA regulation (e.g. software as a medical device)
    3. Reimbursement standards
  3. Interoperability
    1. Standards and design
    2. 21st Century Cures Act
  4. Data privacy and security
    1. HIPAA and FTC
    2. State laws
    3. FDA cybersecurity
  5. Fraud and abuse
    1. Self-referral prohibitions (e.g. Stark Law)
    2. Anti-Kickback laws
    3. False claims
  6. 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

Compton, Lara
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

Hindmand, Rick
Rick L. Hindmand

Counsel
McDonald Hopkins

Mr. Hindman focuses his practice on healthcare regulatory, data privacy, cybersecurity, corporate, and...  |  Read More

Zegarelli, Benjamin
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

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