Thursday 21 February 2019
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Healthcare m-Health Apps to be Certified before FDCA Approval; What is Xcertia?

Healthcare m-Health Apps to be Certified before FDCA Approval; What is Xcertia?

In June 2017, the FDA made a game-changing announcement regarding mHealth—specifically, the ever-increasing mobile health apps on the market. Commissioner Scott Gottlieb published a blog stating that the FDA’s new Digital Health Innovation Plan would redefine the regulation of digital health products, providing more clarity when it comes to overseeing clinical technology. Gottlieb believes that by eliminating regulatory ambiguity in this field, innovators will be encouraged to invest time and resources into further advancing digital health technology. He has also hinted at a regulatory approach similar to the TSA’s precheck program, incorporating a “third party certification program” that would streamline higher risk devices for FDA evaluation, while lower risk products could be marketed without FDA approval.

Clarity for the m-health industry

The digital healthcare industry has been thrilled by this news of the FDA providing more clarity when it comes to overseeing technology, software, devices, and other digital health tools. This is not surprising, considering that according to last year’s study, over 318,000 health apps are currently available, and more than 200 health apps are being added every day. In addition, FDA’s vague regulation process has been a concern in the healthcare industry for some time now. Gottlieb’s vision for the mHealth market aims to keep its numbers growing by simplifying the FDA approval process for app developers and innovators.

While the FDA is still finalizing this broad initiative, however, there is still a serious need for mHealth products to meet certain standards to ensure quality and safety. Without FDA regulation, how will consumers know which of the more than 300,000 mobile apps are reliable, accurate, secure, or even operable? If some apps and devices are subject to FDA regulation and others are not, how will physicians decide which applications they should integrate into their practice? For the mHealth industry to continue flourishing, providers need a reliable means of validating apps, devices, and technology.

Xcertia to smooth out certification process

In December 2017, four major health corporations answered this call. Xcertia, a nonprofit, multi-stakeholder collaboration, was formed to establish a new set of guidelines for mHealth apps. It includes the American Heart Association (AHA), the American Medical Association (AMA), DHX Group, and the Healthcare Information and Management Systems Society (HIMSS).

Xcertia’s mission is to develop and promote best practices for mobile health apps to follow going forward. As the founders eloquently describe: “The collaboration builds on each organization’s ongoing efforts to foster safe, effective, and reputable health technologies, while complementing our mutual commitment to advancing innovation in medicine, and improving the health of the nation. Our combined expertise, along with a diverse membership, will leverage the insights of clinicians, patients, and industry experts to help improve patient care.”

Xcertia’s guidelines currently focus on 4 important areas:

  1.  Operability –whether a mobile health app installs, loads, and runs in a manner that provides    a reasonable user experience.
  2.  Privacy – whether a mobile app protects the user’s information, including Protected Health   Information (PHI) in full compliance with all applicable laws, rules and regulations.
  3.  Security – if the application is protected from external threats.
  4.  Content – whether the information provided in the mobile health app is current and   accurate.

Each of these categories are fully outlined on Xcertia’s website, where consumers, developers, payers, clinicians, and academia are invited to provide constructive feedback and input throughout the rest of January 2018. According to their website, Xcertia guidelines will be updated annually, and upon completion of each update, the guidelines will once again be made available for public comment.

Collaboration will speed up distribution of new apps

As digital health technology continues to grow at a rapid pace, Xcertia’s open and collaborative approach to regulation is the perfect solution. By seeking feedback from their broad and diverse audience, Xcertia is creating a comprehensive framework of principles that accurately represent the market, and that will ultimately have a positive impact on the mobile health app industry’s trajectory. Over the years, the FDA has obtained a bad reputation for slowing down the release and distribution of apps because of ambiguous (and often tedious) regulation policies. But even with the positive changes that Commissioner Gottlieb has proposed for the future, mHealth is still lacking the structured standards needed to keep thriving. That’s where Xcertia steps up to the plate in a collaborative and positive way, encouraging cooperation and feedback from everyone involved.

In summary, it seems clear that the future of mHealth is looking very bright! App developers and innovators can look forward to simpler and more well-defined regulation processes when it comes to their digital technology; physicians can expect more secure and effective digital health tools to implement into their practice; and patients will have access to better technology to monitor their health and wellness in their daily lives.


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