FDA’s Newly Proposed Regulatory Framework for Artificial Intelligence and Machine Learning: What You Need to Know

By Catherine Mayone, Managing Partner, Publicis Health Consulting Services

The “CliffsNotes”

  • Are an extension of an actual medical device, such as those that control the delivery of insulin on an insulin pump;
  • Use a mobile platform for medical device functions, such as an attachment of a blood glucose strip reader to a mobile platform to function as a glucose meter;
  • Perform patient-specific analysis, diagnosis, or treatment recommendations, such as those that use patient-specific parameters to calculate dosage.

Examples of Mobile Medical Applications and AI/ML

The Next Generation is Digital Therapeutics

  • Click Therapeutics, Inc. was the first company to trademark the phrase “Digital Therapeutics” on October 27, 2012. The company describes its mission as:
    Click Therapeutics, Inc. develops and commercializes software as prescription medical treatments for people with unmet medical needs. Through cognitive and neurobehavioral mechanisms, Click’s Digital Therapeutics™ enable change within individuals, and are designed to be used independently or in conjunction with biomedical treatments.
  • Pear Therapeutics, Inc., founded in 2013, puts a finer point on digital therapeutics, describing themselves as pioneers in Prescription Digital Therapeutics (PDTs), operating at the intersection of biology and software technology. The company defines PDTs as software-based disease treatments that are designed to directly treat disease, tested for safety and efficacy in randomized clinical trials, evaluated by FDA, and prescribed by healthcare providers. PDTs are designed and tested much like traditional prescription drugs with one distinction: rather than swallowing a pill or taking an injection, patients are treated with software. From the company’s website:
    Pear Therapeutics discovers, develops, and delivers clinically-validated software-based therapeutics to provide better outcomes for patients, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payers. Every day, we push the boundaries of technology to transform medicine.

Our POV: FDA and technology are ahead of industry

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