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FDA Proposes Health Apps Guidelines

Attempting to keep up with the fast moving convergence of medicine and technology, the U.S. Food and Drug Administration yesterday announced draft guidelines for how the agency proposes oversight of certain mobile medical applications (apps) that are designed for use on smart phones and other mobile computing devices.

The proposed guidelines are meant to encourage the development of new apps and will not regulate the use of smart phones or tablets. However, since the proposed guidelines may significantly impact how medical apps can be developed and used by healthcare providers, the FDA is inviting manufacturers, clinicians and consumers to submit comments. To help our clients make sense of the draft guidelines and the FDA’s request for comments,below is a brief summary of the guidance document and an overview of the type of medical apps included in the FDA guidelines. CCC will continue to monitor the situation and provide updates as necessary.

Regulated Apps

The draft guidelines define only a subset of mobile medical apps designed to be used by healthcare professionals and perform a medical function similar to, for example, a medical device.

This subset includes mobile medical apps that:

• Are used as an accessory to medical device already regulated by the FDA. For example, an app that allows a health care professional to make a specific diagnosis by viewing an X-ray on a smart phone or a mobile tablet.
• Transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices. For example, an app that turns a smartphone into an ECG machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.
• Allow the user to input patient-specific information and using formulas or processing algorithms - output a patient-specific result, diagnosis, or treatment recommendation to be used in clinical practice or to assist in making clinical decisions. Examples include mobile apps that provide a questionnaire for collecting patient-specific lab results and compute the prognosis of a particular condition or disease, perform calculations that result in an index or score, calculate dosage for a specific medication or radiation treatment, or provide recommendations that aid a clinician in making a diagnosis or selecting a specific treatment for a patient.

Importantly, the guidelines do not cover a wide array of apps deemed by the FDA to present lower risk to patients, which include apps that:

• Are electronic "copies" of medical textbooks, teaching aids or reference materials, or are solely used to provide clinicians with training or reinforce training previously received.
• Are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness. Medical apps which are not intended for curing, treating, seeking treatment for diagnosing a specific disease, disorder, patient state, or any specific, identifiable health condition.
• Only automate general office operations with functionalities that include billing, inventory, appointments, or insurance transactions.
• Perform the functionality of an electronic health record system or personal health record system.

Feedback Welcome

If you want to provide input on FDA’s proposal, you can submit your comment online until October 20th 2011 at http://www.regulations.gov/ or in writing to:

Division of Dockets Management

Food and Drug Administration

5630 Fishers Lane, Rm. 1061

Rockville, MD 20852

Want to know more?

Please contact us if you have any questions or need any further information.

Ritesh Patel | Bryan Kaye | Jos Stella