FDA Shares Its Plan for Digital Health Tool Oversight and Facilities Should Take Note

November 16, 2019
FDA Digital Health
In September 2019, the U.S. Food and Drug Administration (FDA) released a set of guidelines designed to continue encouraging innovative approaches for developing digital health tools.

The guidelines, which were created to enable efficient and modern regulatory oversight of those digital tools, were developed in response to questions about how the FDA regulates the tools, especially as they’re becoming more popular. The agency noted that the technologies can help everyone along the healthcare continuum.

“Patients, their families and their healthcare 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,” according to the FDA. “These tools provide patients with a wealth of easily-accessible information that can help them make better and more efficient decisions, take steps to improve their lifestyles and health choices, and experience better outcomes.”


The way the FDA regulates products is designed to foster, not inhibit, innovation, according to the agency. Its goal is to advance digital health policies that provide regulatory oversight, yet also promote the use of rapidly evolving digital products. The agency’s approach to regulating these heath tools has not changed since the release of its Digital Health Innovation Action Plan in 2017.

“Our plan outlined our efforts to reimagine the FDA’s approach to ensure all Americans have timely access to high-quality, safe and effective digital health products,” according to the agency. As part of the 2017 plan, the FDA launched several initiatives. This includes testing a digital health software precertification pilot program, called Pre-Cert, and taking steps to modernize its policies.

The new guidelines help address key provisions of the 21st Century Cures Act, according to the FDA. As part of the guidelines, the FDA provides clarity about where it sees its role in advancing safe and effective digital health technologies.

“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,” the FDA explained.


The FDA’s first guidance document focuses on clinical decision support software . The guidance is based on a draft published in 2017, which has now been revised and updated.

“We recognize that software that provides clinical decision support (CDS) has many uses, including helping providers, and ultimately patients, identify the most appropriate treatment plan for their disease or condition,” the FDA noted.

CDS software programs are designed to inform physicians in their clinical management of patients. Software that analyzes family history, electronic health record data, prescription patterns and geographical data to help healthcare professionals identify patients who may be at risk for opioid addiction is one example of how CDS can be used.

“This technology has enormous potential to improve clinical decision making,” the FDA pointed out. “We want to encourage developers to create, adapt and expand the functionalities of their software to support providers in diagnosing and treating diseases, while also ensuring the software doesn’t introduce unacceptable risk to the patient.”

The guidance clarifies the agency’s oversight of CDS products and includes a risk-based categorization of software products based on the risk to patients if a software product malfunctions. This is in response to feedback the FDA received from its draft guidance in 2017. The final document, “Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations,” establishes common principles for all stakeholders, including regulators, to promote safe innovation and protect patient safety.


The FDA wants to “encourage innovation in the ever-changing field of digital health and protect the public health.” That’s good news for manufacturers of digital health tools that may have felt their products were in a gray zone when it came to FDA regulations. The agency’s guidelines will not, for example, affect Provista members using digital tools or the suppliers who provide them.

In addition, the agency’s guidelines explain its oversight, or lack thereof, for popular digital health products used by consumers. “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,” it said.

These types of technologies typically pose a low risk to patients, but they can provide great value to consumers and the healthcare system. In fact, physicians can include wearables in their health plans to help their patients.

With the FDA’s new guidelines, manufacturers and healthcare providers can continue to benefit from the current healthcare environment that’s moving toward digitalization.

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