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FDA Moving Forward with New Regulatory Approach to Digital Health

June 16, 2017
by Heather Landi
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The U.S. Food and Drug Administration (FDA) is moving forward on a broad initiative focused on fostering new innovation in digital health, and one major part of this initiative will be a Digital Health Innovation Plan outlining how devices will be regulated, according to FDA Commissioner Scott Gottlieb, writing in a blog post.

In the blog post, published Thursday, Gottlieb wrote that the Digital Health Innovation Plan will include a “novel, post-market approach to how we intend to regulate these digital medical devices” that will provide digital medical device developers and health IT startups clarity on the regulations. “To encourage innovation, FDA should carry out its mission to protect and promote the public health through policies that are clear enough for developers to apply them on their own, without having to seek out, on a case-by-case basis, FDA’s position on every individual technological change or iterative software development,” Gottlieb wrote.

Further, the FDA will take steps to advance the goals of the 21st Century Cures Act, he said. The Act revised FDA’s governing statute to, among other things, make clear that certain digital health technologies—such as clinical administrative support software and mobile apps that are intended only for maintaining or encouraging a healthy lifestyle—generally fall outside the scope of FDA regulation.

“Such technologies tend to pose low risk to patients but can provide great value to the health care system. FDA, led by the FDA’s Center for Devices and Radiological Health (CDRH), is working to implement the digital health provisions of the 21st Century Cures Act and, in the coming months, will be publishing guidance to further clarify what falls outside the scope of FDA regulation and to explain how the new statutory provisions affect pre-existing FDA policies,” Gottlieb wrote

The FDA also plans to provide guidance to clarify its position on products that contain multiple software functions, where some fall outside the scope of FDA regulation, but others do not. In addition, FDA will provide new guidance on other technologies that, although not addressed in the 21st Century Cures Act, present low enough risks that FDA does not intend to subject them to certain pre-market regulatory requirements, Gottlieb stated. “Greater certainty regarding what types of digital health technology is subject to regulation and regarding FDA’s compliance policies will not only help foster innovation, but also will help the agency to devote more resources to higher risk priorities,” he wrote.

What’s more, the FDA also will initiate a pilot program exploring the creation of a third-party certification program under which lower risk digital health products could be marketed without FDA premarket review and higher risk products could be marketed with a streamlined FDA premarket review.

“Certification could be used to assess, for example, whether a company consistently and reliably engages in high quality software design and testing (validation) and ongoing maintenance of its software products. Employing a unique pre-certification program for software as a medical device (SaMD) could reduce the time and cost of market entry for digital health technologies,” Gottlieb wrote.

Further, he stated, “This will be the cornerstone to a more efficient, risk-based regulatory framework for overseeing these medical technologies.”

The FDA also wants to explore leveraging the post-market collection of real-world data, which developers could use to support new and evolving product functions. Developers of digital health tools could leverage real-world data gathered through the National Evaluation System for health Technology (NEST) to expedite market entry and subsequent expansion of indications more efficiently, Gottlieb said.

He described NEST as a “federated virtual system for evidence generation composed of strategic alliances among data sources including registries, electronic health records, payer claims, and other sources.”

The Medical Device Innovation Consortium (MDIC), a public-private partnership, is serving as an independent coordinating center that operates NEST. In the coming weeks, MDIC will announce the establishment of a Governing Committee for the NEST Coordinating Center comprised of stakeholder representatives of the ecosystem, such as patients, health care professionals, health care organizations, payers, industry, and government, he stated. Further, he wrote that although FDA does not own or operate NEST, the agency has been establishing strategic alliances among data sources to accelerate NEST’s launch with the initial version of a fully operational system anticipated by the end of 2019.

“Applying this firm-based approach, rather than the traditional product-based approach, combined with leveraging real-world evidence, would create market incentives for greater investment in and growth of the digital health technology industry. Such processes could enable developers to deploy new or updated software more rapidly and would help FDA to better focus our resources,” Gottlieb wrote.

The health IT community generally seems to support the direction that the FDA is taking. Eric Topol, M.D., a cardiologist, geneticist, digital health researcher, and director of the Scripps Translational Science Institute, tweeted “Really good to see FDA, Gottlieb prioritizing digital health to catalyze medicine’s future.”

 

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Geisinger, Merck Co-Develop Patient Communication and Care Delivery Applications

August 17, 2018
by Rajiv Leventhal
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Geisinger Health System and global biopharmaceutical company Merck have collaborated on two new mobile applications that will aim to help patient-provider communication and medication adherence.

According to officials in an announcement this week, the first of the two solutions, the Family Caregiver Application, helps two-way communications and coordination of care for patients and their caregivers. The other workflow solution, the MedTrue application, integrates different medication data sources to assist with medication reconciliation and adherence, resulting in a patient- and healthcare team-verified medication list. 

The applications, which were developed through an ongoing collaboration between Geisinger and Merck, are embedded directly within the electronic medical record (EMR) and in the healthcare provider's workflow. The applications are also accessible to patients and the Family Caregiver Application is accessible to family caregivers. Both workflow solutions can be used remotely.

What’s more, the applications will use SMART on FHIR (Substitutable Medical Applications, Reusable Technologies/Fast Healthcare Interoperability Resources) technology, an open, standards-based platform for utilizing data from disparate EMRs, so both products can be used in healthcare systems anywhere, officials said.

The Family Caregiver application was developed and piloted in oncology, and is designed to be translated to other therapeutic areas to enhance coordination of family caregiving activities among medical and caregiving teams. Meanwhile, officials noted, the driver behind the MedTrue application was the health system’s research which found that about 70 percent of its medication lists were inaccurate.

"Providing these tools for patients and family caregivers — tested within our own system — enables patients to be more active in healthcare decisions and could increase the likelihood that patients will adhere to their treatment plans and lead healthier lives,” said David H. Ledbetter, Ph.D., Geisinger executive vice president and chief scientific officer.

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Fitbit, Blue Cross Blue Shield Launch Mobile Health Partnership

August 13, 2018
by Heather Landi
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San Francisco-based fitness wearable maker Fitbit continues its push into the health plan market with a new digital health deal to incorporate its fitness tracker into health and wellness programs.

Blue Cross Blue Shield Association announced a partnership with Fitbit to include the company’s wearables and fitness trackers in its Blue365 health and wellness program for Blue Cross and Blue Shield (BCBS) members.

Through this program, more than 60 million BCBS members in 23 affiliated health plans to have access to a special offer on Fitbit activity trackers and smartwatches. The deal with BCBSA follows similar partnerships with Humana and UnitedHealthcare.

As part of a commitment to providing consumers with affordable health and wellness products, the Blue365 program also partners with employers to help build a culture of health in the workplace. Employers can either buy in bulk or subsidize a purchase of Fitbit devices for their employees.

“There is no question that increasing activity and moving more is a tremendous benefit that can improve health, and I'm excited Blue365 members will have even more incentives to get and remain healthy by exercising at a pace that's right for them,” Mark Talluto, vice president of strategy and analytics for Blue Cross Blue Shield Association (BCBSA), said in a statement. “This strategic partnership will bring personalized health and wellbeing to the next level, allowing members to put their health first.”

"Fitbit provides a powerful platform to engage consumers by offering data, insights and guidance to help them meet their health goals," Adam Pellegrini, general manager of Fitbit Health Solutions, said. "This partnership is an example of how Fitbit is expanding access to our devices and software so that we can help more people focus on their health and wellness and achieve better health outcomes."

Blue365 is available to members of the 23 participating BCBS companies, as well as the Blue Cross and Blue Shield Government-wide Service Benefit Plan, also known as the Federal Employee Program® (FEP®).

 

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