FDA Issues New Guidance On Digital Health Software

To help ensure digital health apps and software tools safer and more effective, federal regulators have issued new guidelines for manufacturers and developers.

The FDA released a statement on September 26, announcing the issuance of several guidance that address how to make digital health products safe for consumers, which tools require regulatory oversight and which do not. The statement was issued by the FDA’s Principal Deputy Commissioner, Dr. Amy Abernethy.

The six new guidelines continue the efforts of the FDA’s Digital Health Innovation Action Plan, launched in 2017.

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“The guidances issued today continue those efforts announced as part of the Digital Health Innovation Action Plan and address key provisions of the 21st Century Cures Act, that offer additional clarity about where the FDA sees its role in advancing safe and effective digital health technologies,” Abernethy said in the statement. “We’ve taken the goals we were entrusted with by Congress under the Cures Act and are building on these provisions to make sure that we’re adopting the full spirit of the intent to provide a practical oversight framework that is risk based.”

One of the two most sweeping guidelines, the Clinical Decision Support (CDS) Software guidance, is a revised draft guidance that focuses on software that analyzes patient information to help doctors make clinical decisions, such as helping a doctor patients at risk of opioid addiction. The agency hopes the guidance will help software developers continue to create and adapt these programs without adding additional risk to the patient.

The guidance clarifies which CDS software would require oversight. It explains that if the FDA determines the risk to the patient is high then the agency will call for oversight in that area. If the risk is low, the agency will allow developers to work at their discretion.

The FDA also issued the Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act guidance. It outlines which software is no longer considered a medical device, such as mobile apps.

For example, mobile apps intended for maintaining or encouraging healthy diet or lifestyle are now considered outside of the FDA’s regulation because they pose a low risk to patients. More so, they are intended to help patients lead healthier lifestyles, not diagnose, treat, or track a particular condition or disease.

Additionally, the FDA also updated four previously issued FDA final guidance: Final Guidance on Policy for Device Software Functions and Mobile Medical Applications; Final Guidance on General Wellness: Policy for Low Risk Devices; Final Guidance on Off-The-Shelf Software Use in Medical Devices; and Final Guidance on Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices.

Changes to these documents include clarifications regarding which medical software are not subject to FDA regulation.

Each guidance was issued to help spur innovative approaches to the development of digital health tools since digital health tools are being embraced more by health care professionals, patients and families, FDA officials say.

The number of digital health tools being developed is growing steadily, including tools used to report blood glucose levels and smart watches intended to detect atrial fibrillation. FDA officials say the tools should be focused on helping provide patients with easy to access information to help make better decisions and lifestyle choices.


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