The Food and Drug Administration (FDA) has launched new plans to incorporate more digital technology in healthcare, with the aim of improving outcomes and patient care.
FDA commissioner Scott Gottlieb believes that digital health tools are a key way to help accurately diagnose and treat disease. The agency is looking into regulating digital tools as part of the drug review process.
The FDA’s Digital Health Innovation Action Plan, made public last summer, outlined its intention to empower consumers and streamline healthcare and delivery. The latest plans build on last year’s announcement.
A new policy will streamline the way multifunction digital devices are regulated, with the FDA exempting some technologies from regulation, as long as there is no impact on safety or effectiveness. This move is expected to encourage innovation.
Another part of the initiative is the role of digital health in drug development. The FDA will encourage the use of digital applications that monitor medication adherence, update electronic health records, and track treatment symptoms and side effects.
Also, the agency has updated its software pre-certification pilot program, which it will apply to artificial intelligence among other technologies. This would mean that firms could make certain minor changes to devices without having to make a submission each time.
A holistic approach to healthcare
Gottlieb commented, “In addition to empowering patients, digital tools are giving providers a truly holistic view of patient health and function through new data flows. These tools are helping redesign physician workflow to better coordinate patient care.
“The trend towards connectivity and seamless monitoring is reflected in the 51 digital health products authorized by the FDA in 2017. One of those included a sensor embedded in a drug for schizophrenia that can allow patients to share treatment data with their physician through a medical app.
“Digital health also offers real opportunities to improve medical outcomes, enhance efficiency, and reduce costs.”
While the FDA stresses that its priority is to protect and promote public health, the body recognizes that its approach to regulating digital health technologies must work in such a way to keep up with the developments under scrutiny. Patients will therefore hopefully benefit from innovations more rapidly, safe in the knowledge that they are trustworthy.
To read Scott Gottlieb’s comments in full, click here.