Bottom line:
– Am I regulated?
– Yes.
The FTC, in conjunction with HHS and FDA, just released a new mobile health apps interactive tool which — if it reaches its target market — will quickly make clear to digital health app developers that their work is subject to a wide variety of regulatory schema, not just HIPAA. I gave a presentation about this very topic at a recent conference, entitled: Beyond HIPAA: Digital Health Opportunities and Regulatory Land Mines (see my slides at the link).
The regulated community needs to hear this. I’ve been beating the drum out there, as have others, but it is not uncommon for me to encounter sophisticated folks who have come to believe that health care privacy and security concerns begin and end with HIPAA.
David Harlow
The Harlow Group LLC
Health Care Law and Consulting