This document discusses several hot topics in digital health, including privacy laws like GDPR and CCPA, prescribing controlled substances via telemedicine, and the use of artificial intelligence in healthcare. It notes that Congress recently ordered action on prescribing controlled substances without an in-person evaluation. The document also provides examples of how AI is being used in telemedicine to analyze voice tones, images, and detect conditions. Finally, it outlines some legal issues that can arise from the use of AI in healthcare, such as intellectual property, privacy, reimbursement fraud, regulation, and liability.

1. “Hot Topics” in
Digital Health
Joseph P. McMenamin
McMenamin Law Offices, PLLC
VSee
2 October 2019
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2. Disclaimers
 The views expressed are the speaker’s, and not
necessarily those of any of MLO’s clients, nor of VSee.
 No real or apparent conflicts of interest.
 The information offered is intended to be educational.
Providing it does not create an attorney-client relationship
between the speaker and anyone else.
 Presenting theories of liability does not mean the speaker
concedes their validity.
 Naming a product or service is not an endorsement.
 No claim of copyright in clip art.
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3. A Few Hot Topics
 Privacy: GDPR and its American progeny
 California Consumer Protection Act (“CCPA”)
 CFR Part 2 v. Jessie’s Law
 Prescribing controlled substances without previous in-
person evaluation:
 MAT
 Special registration
 2008-19: a dormant provision of Ryan Haight Act
 10/18: Congress orders HHS and AG to act by 10/24/19
 Artificial (“Augmented”) Intelligence in healthcare
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4. AI in Telemedicine:
Clinical Examples
 Voice tone, intensity and coronary artery disease
 Sonde Health
 Alexa: kids’ ear infections, fevers, colds
 Boston Children’s
 Imaging: lung, breast, or colon cancer
 256 Radiology 827, 828 (2010)
 Dermascope: melanoma v. other skin lesions
 26 Health Matrix 123 (2016)
 Identification of Afib
 Lancet 8/1/19 4
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5. AI in Telemedicine:
Examples of Legal Issues
 Intellectual property
 Privacy; data ownership
 Reimbursement; fraud
 Contract
 Regulation: FDA? FTC?
 Tort: professional; product
 Bias?
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6. Questions?
Joseph P. McMenamin, M.D., J.D.
McMenamin Law Offices, PLLC
804-921-4856
mcmenamin@medicalawfirm.com
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