Healthcare and FDA lawyer Michael H. Cohen spoke on telemedicine, mobile medical app (M-health) and wearable health tech legal issues at the Los Angeles County Bar Association’s Healthcare Law Compliance Symposium in Los Angeles. The talk covered legal and regulatory compliance concerns with mobile medical apps, telemedicine, and wearable health tech, including:
- licensing issues
- HIPAA compliance
- FDA mobile medical app and medical device issues
- Medicare, Medi-Cal, and private insurance reimbursement
Telemedicine clients include:
- individual physicians practicing across state lines
- multi-state telemedicine or telehealth companies
- mobile medical app developers
- wearable tech manufacturers
- business associates of these
See the powerpoint: Cohen – Polisky Health Law Compliance Talk FINAL 10am FINAL 10-9-14.
State licensing concerns arise because every state defines and licenses the “practice of medicine,” and the telehealth rule is that the law where the patient is located applies as does the law of the state where the doctor originates (i.e., both remote state and home state). Michael presented a number of strategies that telemedicine clients can deploy to address licensing issues, including:
- understanding which states have tough telehealth laws
- limiting telehealth to consultation with the patient’s physician
- providing “limited and occasional” patient care in the remote state
- obtaining a special purpose telemedicine license
- limiting advice to information and education, with a robust disclaimer in the terms of use
- having a national network of state-specific physicians
- looking to the forwarding thinking model policy on telemedicine by the Federation of State Medical Boards
With respect to FDA mobile medical app issues, Michael spoke about the intended use doctrine and the FDA’s exercise of enforcement discretion as to which mobile apps it will deem a medical device, with concomitant regulatory burdens including medical device establishment registration and device listing, Quality System controls, and determination of classification (Class 1, Class 2 device, etc.) and the ideal path to market for the medical device.
As to future trends of telehealth, mobile health, and wearable health, Michael noted:
- Blurring of lines of between medical advice (regulated) vs. general wellness (education/information)
- Overlap between state-law regulation of physical providers (licensing laws) and federal regulation of healthcare products (FDA rules)
- More ease of licensing and greater reimbursement
- Technology continually outpacing regulation
- Edgy clients pushing technological & regulatory boundaries
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