iPad EHR app certified for meaningful use

In a sure sign of the times, Drchrono, which offers a free electronic health record platform on the iPad, became the first iPad app to receive official ONC-ACTB certification. According to Healthcare IT News, "the drchrono EHR platform has been awarded ambulatory certification (ONC-ATCB) as a Complete EHR by San Luis Obispo, Calif.-based InfoGard, an Office of the National Coordinator (ONC) Authorized Testing and Certification Body (ATCB)". The app tracks a provider's use of the EHR and offers them key metrics to report to CMS, and includes many other features, such as billing and e-prescribing. 

This is a huge step for a mobile EHR app, but its maker's regulatory hurdles may not be over.  Last week, we reported on the FDA potentially regulating the market of mobile healthcare devices and applications. Electronic and personal health records could be exempt from such regulation, unless the FDA adopts a broad definition of "clinical decision support," which includes decisions based on the information given to a provider via the EHR app or device.

Moreover, use of such mobile apps or devices in healthcare presents providers with a very long list of legal concerns. Privacy and security of patient data, compliance with state and federal laws (including Stark and anti-kickback statutes), assumption of risk and liability, along with many other critical issues, should be addressed in the contract between the healthcare provider and vendor of such software.

"iPad EHR gains meaningful use certification," Healthcare IT News (July 29, 2011).

"FDA's mobile medical app guidelines get everybody talking," Healthcare IT News (July 26, 2011).


FDA to regulate some mobile health applications

On July 19, 2011, the U.S. Food and Drug Administration (FDA) issued a guidance regarding the agency's plans to regulate select software applications intended for use on mobile platforms (mobile applications or "mobile apps"). According to the Washington Post, the FDA proposed to regulate only those mobile apps which: (1) act as an accessory to a regulated medical device; (2) turn a mobile device or gadget into a regulated device; and/or (3) make suggestions regarding a patient's diagnosis or treatment. Via the Post:

For example, an app that allows radiologists to view X-rays on an iPad or that turns an Android phone into a heart monitor would be regulated. But an app that stores medical records or provides training videos to physicians would not.

'We wanted to make sure that we are consistent in regulating medical devices so nothing has changed,' [FDA policy adviser Baku] Patel said. If 'somebody makes a stethoscope on an iPhone, it doesn’t change the level of oversight we have of a stethoscope.'

FDA's guidance does not establish any legally enforceable responsibilities, but describes FDA's current thinking on this topic and should be viewed only as recommendations.  The agency will collect input from manufacturers and healthcare providers over the next 90 days.

You can view the full guidance by clicking here.