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The Emerging Legal Landscape of Mobile Healthcare Apps

8 Oct 2014 by Stephen Siciliano

The mobile app market is passing through a “Wild West” phase as potential users hedge their bets and wait on what the final, established order will look like.

But use is still clearly on the rise.

An October study from Manhattan Research tells us that, in 2013, 95 million Americans used their mobile phones either as healthcare tools or as a way to access health information. That’s up from 75 million the previous year.

In a much-publicized 2013 report, the IMS Institute for Healthcare Informatics found 43,700 health or medical apps being sold on iTunes. Of that number, only 159 could track or capture calculators for users to measure their vitals. Researchers also found that only 31 percent of the apps were intended for use by clinicians.

The industry is still working toward a definitive resolution to security and confidentiality issues. Of 43 apps recently reviewed by San Diego-based Privacy Rights Foundation, 72 percent garnered a high- or medium-risk rating.

Providers say they spend a significant amount of time trying to make data useful to caregivers –

without overwhelming them by providing too much. They’re also grappling with the Bring Your Own Device (or BYOD) phenomena: the desire of workers to use their own personal devices and apps at work. Adding to the friction is a similar wish to employ personal cloud storage (BYOC).

Inevitably, friction develops between the organization (with security concerns) and the individual worker (who is literally lending their personal technology to benefit that organization).

Some propose the development of in-house procedures that forbid using personal devices to store proprietary data. Another solution involves the installation of a “sandbox,” or reserved storage area, on personal mobile devices, for sensitive information.

The mobile app medical vision can reduce hospital stays, patient/physician interaction and, ostensibly, costs — all that same time. But patient resistance remains. Assuming the task of monitoring their own behavior via electronic device is not hitting a consumer preference sweet spot … at least not just yet. It’s like self-checkout at the grocery store: the technology is there, but not everyone is doing it.

Nor is it easy for providers to bet on mobile apps to produce fewer visits and stays, and provide a boon to their business. More visits mean more payments. Less visits… That deadlock could change if government or private insurers ever come around to reimbursing for mobile apps.

In the meantime, a lack of clear professional guidelines results in a hesitance on the part of providers to purchase mobile apps.

But this appears to be the year the federal government lays the regulatory groundwork for mobile applications. The Food and Drug Administration’s September guidance for software developers signaled that the FDA would not regulate most mobile medical applications, focusing instead on those apps meeting the definition of a medical device and posing significant risks to patients. Nor would the FDA regulate consumer-use mobile devices, such as smartphones and tablets, only “mobile apps performing medical device functions.”

But what’s good for the software-developer-goose still may not be as good for the software-prescribing-gander, because the proliferation of mobile apps overwhelms. The Food and Drug Administration Safety and Innovation Act (FDASIA) Workgroup on Health IT regulation found that apps with similar claims offered widely divergent performances.

Chief information officers who need help sorting through the app avalanche for performance quality or safety may not get what they need from the FDA’s proposed hands-off approach.

There is no new sheriff in town, he’s merely passing through in search of the riskiest citizens.

On the legislative front, the cart may be rolling out before the horse is harnessed.

The Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act, proposed by Rep. Marsha Blackburn (R-TN), would identify a single category of software products to be regulated by FDA, and place the larger number into one of two categories beyond its purview.

In September, the FDASIA workgroup issued recommendations for regulating Health IT. These included federal pre-market oversight for medical device accessories and post-market reporting of medical errors or adverse events caused by health IT tools. These will be rolled into a report expected soon from the FDA, the Federal Communications Commission and the Office of the National Coordinator for Health Information Technology.

The mHealth Regulatory Coalition wants Congress to wait until that report comes out and avoid a piecemeal approach. The Health IT Now Coalition fears that regulatory uncertainty is holding up the deployment of mobile health IT products already in use overseas.

The European Union utilizes private entities to certify low-risk technologies such as electronic health records employed at hospitals. These “Notified Bodies” report safety data to regional health agencies.

Domestically, where the curating of apps is lacking, the European approach has a faint echo.

Happtique, a New York-based firm, has developed a health app certification program with an eye toward helping developers ensure safety and effectiveness. In December, the company certified 19 mobile apps under the program.

In January, IMS Health launched “AppScript,” claiming that it classifies and evaluates some 40,000 mobile apps for everything from peer review and certifications to their potential for improving outcomes.

Although a future with pervasive mobile device use seems certain, the world where mobile apps are integrated into a comprehensive healthcare and wellness information system, remains a work-in-progress.