“Foster, not inhibit, innovation”: US FDA guidance on digital health tools clears lifestyle apps of oversight

30 Sep 2019 --- The US Food and Drug Administration (FDA) has issued guidance on how it will regulate “novel, swiftly evolving” digital health tools, such as mobile health software and products that use artificial intelligence (AI). The new guidelines include the assertion that lifestyle apps will be officially free of FDA oversight. Digital software for health is increasingly popular among both the public and health professionals and the FDA notes that its approach “must foster, not inhibit, innovation.”

“Patients, their families and their health care professionals are increasingly embracing digital health technologies to inform everyday decisions, from tools that more easily report blood glucose levels to smart watches that can detect atrial fibrillation,” says an agency statement.

“We’re making clear that certain digital health technologies – such as mobile apps that are intended only for maintaining or encouraging a healthy lifestyle – generally fall outside the scope of the FDA’s regulation. Such technologies tend to pose a low risk to patients, but can provide great value to consumers and the healthcare system,” continues the statement.

The FDA decision was shared within the final guidance Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act which addresses other digital health provisions included in the Cures Act.

Health care professionals are increasingly embracing digital health technologies to inform everyday decisions, says FDA.Personalized nutritional planning, particularly in the “digiceuticals” sphere, have been an emergent trend coming into fruition over the last few years. Increasingly, leading companies are launching mobile platforms to be used in conjunction with their products, which assist consumers with planning, achieving and sustaining their health and nutritional benchmarks. When synergized with AI, these technologies can prove to be highly attractive to health-conscious, digital-savvy consumers of all ages, who prioritize functionality and efficiency.

For example, in July, the results of a “breakthrough” study in the diet-based treatment of Crohn’s disease lent support to Nestlé Health Science’s new mobile app for patients, ModuLife, which is incorporating this knowledge in its therapeutic practice.

In April, Dutch multinational Royal DSM partnered with digital health provider Panaceutics to bring to the market “affordable” products geared specifically towards health and wellness.

Meanwhile, a paper published by FoodMinds noted that AI-driven offerings will be a key part of the huge growth which we will see in personalized nutrition in the next three to five years. She adds that whether by creating more accurate feedback loops that encourage ongoing optimization, or simply by prompting greater vigilance around tracking health behaviors, AI and innovative technologies can boost efficacy and offer a greater feeling of control for the end-user.

Clinical decision software
The FDA guidance also covered digital health technologies that can be utilized by health professionals, such as clinical decision support (CDS) software. This includes software that analyzes family history, electronic health record data, prescription patterns and geographical data in order to help health care professionals identify patients who may be at risk for opioid addiction.

The press release says the clinical decision support (CDS) guidance is supposed to focus regulatory oversight on CDS functions that are intended to affect clinical management of serious or critical conditions.

“An example of a product we would focus our oversight on would be CDS that identifies hospitalized, Type 1 diabetic patients at increased risk of postoperative cardiovascular events and which does not explain why the software made that identification to the health care professional,” says the press release.

“In this case, if the CDS provides information that is not accurate [e.g., inappropriately identifies a patient as low risk when he is high risk], then any misidentification could lead to inappropriate treatment and patient harm. Since the potential for patient harm is significant, FDA regulation plays an important role in evaluating the software’s safety and effectiveness,” concludes the FDA.

By Laxmi Haigh

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