From: HealthITSecurity.com
Author Name Patrick Ouellette
There has been a great deal of talk lately around which federal regulatory bodies have jurisdiction over keeping data private and secure in healthcare. While the battle between Federal Trade Commission (FTC) and LabMD mercifully ended last week, that was just one area of regulatory confusion in healthcare. How far the Food and Drug Administration (FDA) reach extends to mHealth security is also an interesting topic of discussion.
Pepper Hamilton attorney Sharon Klein, head of the firm’s Privacy, Security and Data Protection practice, discussed with HealthITSecurity.com the regulatory framework for mHealth, the FDA’s cybersecurity guidance and steps healthcare companies can take to reduce risk.
How involved is the FDA getting with mHealth security?
Obviously, we just got the guidance out late last year in terms of mobile medical applications and cybersecurity and one on social media earlier this year. So the FDA is definitely being an activist in this area. They made it clear back in the 1980s that they planned on regulating EHRs – it only took them 26 years.
How far-reaching is its jurisdiction for mHealth?
The FDA definitely has very broad powers and is flexing its muscles now because legislation has stalled and therefore the regulators are filling the gaps and doing their jobs in terms of ensuring, in the FDA’s case, public safety and the intersection between mobile apps and their connection to patient care. The FDA’s announcements were in three “buckets” – Here’s what they are going to regulate right now, here are the items that they have discretion over but they’ve chosen not to exercise it right now and then there’s the things that they really don’t care about.
Do the number of federal regulators in healthcare complicate matters for providers?
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