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FDA adds digital health technology to 2018 policy roadmap

In an effort to help consumers make informed health decisions, the Food and Drug Administration (FDA) renewed its commitment to digital health technology in its 2018 strategic policy roadmap.

The FDA said in its roadmap that digital health not only allows consumers to “take more effective control of their care,” but also allows clinicians to “provide better medical care.” The agency also said it will adapt its traditional approaches to regulation to address the challenges of digital health technology, using its previously announced Pre-Certification Pilot Program.

The goal of the program is to develop a tailored approach to regulating digital health technology by first concentrating on the developer of the technology and not the technology itself, as the agency currently does for traditional medical devices. This will allow change to occur more quickly to accommodate the faster pace of innovation in digital health technology, the FDA said.

FDA Commissioner Scott Gottlieb, M.D., said in a statement that the roadmap isn’t intended to be a traditional strategic plan and that it is not a comprehensive list of policies the agency will focus on in 2018. Instead, it is a way to provide transparency about the FDA’s policy undertakings to organizations and people affected by FDA oversight. By focusing on new areas like digital health technology, the agency “will optimize our resources to achieve clear deliverables that will yield results over the next two years.”

The FDA previously issued draft guidance that loosened its regulations on certain technologies, such as mobile apps that help consumers manage their weight or track their steps. The agency considers these types of apps low risk for causing harm; rather, the data collected and managed by these apps can be valuable to the consumer.

The FDA’s focus on digital health technology is in line with an industry trend that shows no sign of slowing down, as investments in digital health hit $3.5 billion in the first half of 2017 alone.

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