The shift in the U.S. Food and Drug Administration’s approach to regulating some mobile health applications is benefiting companies such as Ideomed. The 4-year old company’s app Abriiz helps users track chronic conditions, such as asthma and diabetes, by integrating data from mobile health devices.
Abriiz is also considered a medical device data system, an area the FDA is deregulating so it can focus more attention on medical devices it believes require greater oversight.
In a phone interview, Ideomed CEO Keith Brophy gave a sense of what the process was like. “We expected that we would have to file a class 1 device clearance application, but there was definitely a lot of uncertainty about it.”
The decision clears the way for Abriiz to be connected to other FDA-regulated devices including blood glucose monitors, pulse oximeters, scales and blood pressure cuffs. Brophy believes the decision will lead to a significant acceleration of personal health devices.
In order to accomplish the Triple Aim, mobile health solutions need to be broadly accepted by physicians and other stakeholders and readily recommended to their patients, Brophy observed. The FDA’s recognition of Abriiz as a medical device needing no further regulatory requirements goes a long way toward giving physicians the confidence they need to recommend Abriiz.
Referencing Apple’s conversations with the FDA over its HealthKit platform, director of marketing Brian Mack said it was pleased and surprised by the tenor of those conversations. “It was really not what you might expect based on the reputation of the FDA. It showed a great deal of understanding that this era of technology will be a game-changer and they could not address the level of technology to the same level that they could pharma.”
You get that impression in a blog post by Bakul Patel, a senior policy adviser in the FDA’s Center for Devices and Radiological Health. He explained the rationale behind the move to scale back regulation for medical device data:
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
“Medical device data systems are critical to the success of digital health because they transfer, store, convert, and display a variety of information from medical devices critical to understanding an individual’s health. These systems are the foundation for intercommunication and interoperability among devices and between medical devices and other health IT.
“Because they pose such a low risk, FDA does not intend to enforce compliance with the regulatory controls that apply to medical device data systems. FDA believes that this will encourage greater innovation in the development and maturation of these systems.”
Part of its preparation for working with the FDA also involved sitting down with the Association for Competitive Technology, which provided valuable feedback.
Brophy said medical device manufacturers have reached out to the company to see if their devices can plug into Ideomed’s app as well as early-stage companies. “We are definitely getting approached by emerging device companies. Generally, these companies have very targeted devices for very specific aspects of chronic conditions, such as congestive heart failure, diabetes and managing COPD. It reflects that the cost of device development is going down significantly.”
