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FDA Announces Precertification Program For Digital Health Tools

Posted on October 5, 2017 I Written By

Anne Zieger is a healthcare journalist who has written about the industry for 30 years. Her work has appeared in all of the leading healthcare industry publications, and she's served as editor in chief of several healthcare B2B sites.

The FDA has recruited some the world’s top technology and medical companies to help it pilot test a program under which digital health software could be marketed without going through the through the agency’s entire certification process.

The participants, which include Apple, Fitbit, Johnson & Johnson, Samsung and Roche, will give the agency access to the measures they’re using to develop, test and maintain their software, and also how they collect post-market data.

Once armed with this information, the FDA will leverage it to determine the key metrics and performance indicators it uses to see if digital health software meets its quality standards.

Companies that meet these new standards could become pre-certified, a status which grants them a far easier path to certification than in the past. This represents a broad shift in the FDA’s regulatory philosophy, “looking first at the software developer digital health technology developer, not the product,” according to a report previously released by the agency.

If the pilot works as planned, the FDA is considering making some significant changes to the certification process. If their processes pass muster, pre-certified companies may be allowed to submit less information to the FDA than they currently must before marketing a new digital health tool.  The agency is also considering the more radical step of allowing pre-certified companies to avoid submitting a product for premarket review in some cases. (It’s worth noting that these rules would apply to lower-risk settings.)

The prospect of pre-certifying companies does raise some concerns. In truth, the argument could be made that digital health software should be regulated more tightly, not less. In particular, the mobile healthcare world is still something of a lawless frontier, with very few apps facing privacy, security or accuracy oversight.

The fact is, it’s little wonder that physicians aren’t comfortable using mobile health app data given how loosely it can be constructed at times, not to mention the reality that it might not even measure basic vital signs reliably.

It’s not that the healthcare industry isn’t aware of these issues. about a year ago, a group of healthcare organizations including HIMSS, the American Medical Association and the American Heart Association came together to develop a framework of principles dressing app quality. Still, that’s far short of establishing a certification body.

On the other hand, the FDA does have a point when it notes that a pre-certification program could make it easier for useful digital health tools to reach the marketplace. Assuming the program is constructed well, it seems to me that this is a good idea.

True, it’s pretty unusual to see the FDA loosen up its certification process – a fairly progressive move for a stodgy agency – while the industry fails to self-regulate, but it’s a welcome change of style. I guess digital health really is changing things up.


Connecting Wireless, Mobile and the Future of Healthcare: Healthcare Honchos Address Issues Head-on

Posted on April 23, 2011 I Written By

There are tons of conferences out there relating to healthcare, and an increasing number are related to technology and specifically to mobile healthcare.  This conference focuses specifically on taking advantage of the opportunities that wireless and mobile healthcare provides.  Plus, it is in San Diego so you can’t really miss there.

Convergence Summit Runs May 10-12, 2011 in San Diego

How will advances in mobile technology improve access to healthcare in the U.S. and globally? What role will wireless technology play in improving productivity in healthcare? Will the new regulations outlined recently by the Health and Human Services department regarding Accountable Care Organizations (ACO’s) play a role? Wireless and mobile healthcare may well form the basis for new methods of healthcare delivery—for instance, “to treat an individual patient across care settings—including doctor’s offices, hospitals, and long-term care facilities” (CMS Office of Media Affairs).

These and other wireless healthcare issues are to be the star subjects of the Convergence Summit, a three-day event to be held May 10-12, 2011 in San Diego, hosted by the Wireless-Life Sciences Alliance (WLSA) and its partner TripleTree, LLC.

Featured speakers include:

  • Paul Jacobs, Ph.D, CEO of Qualcomm, who is slated to give the opening-day keynote on May 10, 2011;
  • Bill McGuire, M.D., the former CEO of United Healthcare, who is to open the second day of the summit on May 11, 2011;
  • Harry Greenspun, M.D., chief medical officer at Dell, kicks off the final day on May 12, 2011.

A post-lunch keynote on May 12 is to feature Dan Buettner, the New York Times best-selling author of, most recently, Thrive: Finding Happiness in the Blue Zones Way (National Geographic, 2010).

The Convergence Summit is an exclusive gathering of executives, investors, developers and policy makers who come together annually to address issues of advancing innovations in wireless and mobile healthcare technology. Other speakers include John Kelliher, The Marwood Group; Richard Migliori, Optum; Preetha Reddy, Apollo Health Systems; and Tien Tzuo, Zuora.

“Wireless coverage is nearly ubiquitous within the U.S. and many parts of the world. This opens up opportunities for advancing healthcare globally in ways we haven’t even dreamed of,” says TripleTree senior director and chief marketing officer Chris Hoffmann.

WLSA organizers devote each day to a forward-looking theme about uniting wireless and healthcare. Conference themes for this, the sixth annual Convergence Summit, include “Defining a global platform for wireless and mobile health” (Day 1), “Best approaches for streamlining patient-doctor interactions” (Day 2) and “The convergence of mobile and cloud, and the simplification of healthcare solutions” (Day 3). Day 2 also features the presentation of the third annual I Awards, sponsored exclusively by TripleTree, for innovation in wireless healthcare.

Several lively forums dovetail with the conference themes; the forums are open exchanges, with executives, innovators, investors and others brainstorming the topics. No PowerPoint presentations allowed!

Conference participants for the three days of forums include representatives from large and small companies on the cutting edge of the convergence of wireless and healthcare. A sampling of participating companies includes Appirio, Ascension Health, AT&T, Banner Health, CareFusion, Dell, EmpowHER, Healthagen, InstyMeds, WhiteGlove House Call, Johnson & Johnson, Jitterbug, Mental Workout, Optum, Procter and Gamble, RehabCare, Teladoc and Telcare. A total of 300-400 participants are expected to attend the summit.

“When we put all these people in the same room—innovators and users, entrepreneurs and HMO chiefs, technology wizards and policy wonks—the mix is exhilarating,” TripleTree’s Hoffmann says. “The future of healthcare swirls into shape before your eyes.”

The WLSA is an international nonprofit think tank that puts CEOs from the world’s most innovative wireless and mobile health companies together with global leaders in healthcare and technology and financial sponsors.

TripleTree, LLC, a founding member of the WLSA, is an independent investment bank and strategic advisor providing growth companies in healthcare and other technology-enabled vertical industries with merger and acquisition, private capital and principal investing services.

For more information about the 2011 WLSA Convergence Summit, go to