Why regulatory action will play a key role in mHealth advancements

For mHealth technology to deliver on all its promises there needs to be a concerted effort by government regulators to catch up with the speed of innovation, writes Mark Hines, a litigator at Gowling Lafleur Henderson LLP in Canada, in a column at Lexology.

"[Mobile health] is challenging the effectiveness of health and privacy regulation in Canada. While regulators have taken certain steps to address mHealth, the extent of technological change raises further questions about the suitability of existing regulation in protecting the public," he says. "It has become more difficult for manufacturers and app developers to determine the legislation with which they must comply and the regulators under whose jurisdiction they fall."

In the U.S., lawmakers are calling on federal agencies to address such questions regarding privacy, healthcare data access and use and delve deeper into potential regulations of mHealth devices. In response the Federal Trade Commission has indicated it has no desire to develop more rules, at least within the near future.

Vendors are also activity talking with regulators. In early November Apple and FTC officials discussed data sharing and user privacy as it relates to Apple's HealthKit and its impending watch, with the agency seeking assurance Apple will not sell data to third-party vendors. 

The fast mHealth tech development, says Hines, raises questions regarding privacy rules that need to addressed on the regulatory front. Despite guidance documents that have been released regarding medical apps, more needs to be done, he says.

"Health Canada regulates medical devices that are 'imported for sale' or 'sold' in Canada. But does the app qualify as a diagnostic device? What if the app can be downloaded for free? Or, what if the software is hosted by a server in another country?," he writes.

Hines also says the current environment when it comes to regulations creates uncertainty for device makers, as well as for those who may be considering entering the market.

"Over the next few years, regulators ... will need to work with the mhealth industry to create a predictable regulatory environment that is not overly burdensome, permits technological creativity and, most importantly, protects the public," he says.

For more information:
- read the column

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