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FDA issues regulatory guidelines for mobile health care apps as popularity soars

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The FDA issued basic regulatory guidelines this fall regarding mobile medical apps.
The FDA issued basic regulatory guidelines this fall regarding mobile medical apps. - ()

Take two apps and call me in the morning.

Now there's a turn of phrase that may not be as far-fetched as one might think.

Mobile health care apps are soaring in popularity; one estimate projects half a billion people will use them by 2015. They are changing the relationship between doctors and their patients — and between companies and consumers.

And while they have captured the imagination of entrepreneurs and investors, a question remains:

Just what are the rules?

After lengthy debate, the Food and Drug Administration issued some basic regulatory guidelines this fall regarding mobile medical apps. The FDA announcement Sept. 23 brought some resolution to a hot-button topic more than two years after it began investigating the matter.

And while the rules are by no means perfect — and clearly are just the start of a work in progress, they are welcomed by people such as Ben Chodor.

Chodor is the former CEO and founder of Happtique, a mobile health care app aggregator. He is now an investor in Westfield.

"It's still the wild, wild west out there," he said. "No one knows what is going to happen."

Chodor, however, said he is more confident about embracing such ventures now that the government has offered more clarity about how it plans to regulate this technology.

Broadly, the FDA concluded it can regulate mobile apps just like medical devices if the app is intended to treat or diagnose disease, basically when the technology can harm a patient if misused.

Chodor doesn't endorse all the FDA's conclusions. He says the agency's final rules still contains gray areas but he is glad the government made a decision.

"If you're going into this space, and you've read the guidelines, at least you know what you're in for," said Chodor, who in March testified before Congress on the matter. "The FDA coming out with guidelines opens the door a little wider for us.

"Obviously they haven't figured everything out."


Mobile health care apps are touted for their potential to improve communication between physicians and patients, increase adherence to medical prescriptions, help patients locate good doctors and pharmacies, and encourage preventative measures.

Of course you may need an app simply to sift through them all.

Parsippany-based data provider IMS Institute for Healthcare Informatics said there are about 43,000 health-related apps available for download from the Apple iTunes store. And IMS says a little more than 16,000 are directly related to patient health and treatment.

But how many of those need to be monitored?

It might be easier to start with those that don't.

Many health care apps focus on general wellness, the Nike FitBit activity and exercise trackers among the most widely used. Calorie counters and other dietary tools are typically regarded as low-risk. There's no need to monitor those.

The FDA instead said it will focus on apps that function as accessories to medical devices and have serious health consequences, such as apps that allow a doctor to make a specific diagnosis by viewing a medical image from a smartphone.

The FDA will also regulate apps that transform a mobile platform into a medical device, such as apps that turn a smartphone into an electrocardiogram machine that detects abnormal heart rhythms or determines whether the patient is experiencing a heart attack.

Most apps don't fit those categories, bringing relief to Clark Lagemann.

Lagemann is the co-founder of Health Options Worldwide, whose flagship product myhint encourages wellness by recommending schedules to seek preventative measures based on the user's personal health data. He doesn't expect overbearing regulation.

"This is a good middle road," Lagemann said. "My concern, before the guidelines came out, is they would overdo it and stifle innovation."

Others worry regulators may not be doing enough.

Former Merck executive Nick Spring, who runs Humanitas Consulting LLC, a Jenkintown, Pa. firm advising life science and technology companies in New Jersey and Pennsylvania, worries that a vast gray area exists between harmless wellness apps and those the FDA says it will regulate.

Spring says many apps haven't been clearly categorized — citing those helping to manage diabetes or obesity as examples.

Of those that have been categorized, few have been approved as the FDA has approved about 100 mobile medical apps in the last decade, including 40 in the past two years.

As the FDA begins approving more apps, Spring figures more companies will seek that distinction.

"Say you are a doctor and you have a choice between recommending one app which is FDA approved and one which is not, which are you going to use?" Spring said. "So there is a positive commercial angle."


Spring is advising clients unsure about the FDA ramifications to initiate dialogue with the agency as a precaution.

"You have to be proactive," he said. "All mobile health companies would be well advised to get their products FDA-approved."

Gaining FDA approval will help apps that function like medical devices be better able to market their product to doctors.

And to investors.

Just ask Chodor, whose past company, Happtique, holds patent-pending technology that enables doctors to prescribe apps.

Chodor says developers of mobile medical apps will have an easier time raising capital once they gain the endorsement of doctors and regulators. Such credibility is needed to persuade payers, mainly insurance companies, to reimburse the cost of recommended apps, a crucial step needed to make them more viable in the marketplace.

"The only reason people invest in clinical apps is because they think someone is going to pay for it," he said. "They're not betting it's going to be the patient. They're betting it's going to be the payers."

Jeffrey Nicholas, a securities and finance lawyer at Lawrenceville law firm Fox Rotschild LLP, who advises venture capital investors, said some ambiguity remains involving what are known as clinical decision support apps. Such apps — like calculators — are not medical devices but can be used by patients and clinicians to support medical decisions.

"If it's unclear as to what's covered, investors may balk at providing capital until this is cleared up," Nicholas said. "There are procedures in place to have that dialogue with the FDA."

Otherwise, he said his clients are generally happier now a few months ago.

"Even though the final guidance isn't perfect, it's better to have some guidance than no guidance," Nicholas said. "There are some unanswered questions that commentators on the law have brought up, but these guidelines have narrowed the scope of ambiguity. There are fewer unanswered questions than there used to be.

"People can live and work and run their companies within this guidance," Nicholas said. "There's comfort knowing the rules of the road have been issued."

E-mail to: tomz@njbiz.com
On Twitter: @biztzanki

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