With the industry generally supporting recent Food and Drug Administration guidance on medical mobile applications, an HDM blogger warns that the guidance carries some consequences and could unlevel the playing field.
In “Mobile Health Gets Political,” Zachary Landman, M.D., chief medical officer at mobile app developer DoctorBase, worries that large communications companies could benefit at the expense of smaller outfits, hurting competition and innovation. Among other concerns, he writes: “Given the regulatory hurdles for data gathering applications, investments may shift away from startups in this industry. Those who do continue in the regulated industry may be forced to consolidate resources, form partnerships, and lobby for better defined Medicare or payer reimbursement categories for these types of medical technology.”
Landman’s arguments generated comments from multiple HDM readers:
Thomas S.: “It does annoy me a little that the smaller companies might get squeezed out because of new regulations. But, when it comes to health, especially diagnosing a problem, I do think we need to be careful with what comes to the market.”
Andre S.: “It is definitely the new Wild Wild West. Just like the internet boom in the 90's, everyone that has an idea about something related to Health Tech 2.0 will try to create something ‘new’ for the market. The FDA also sees opportunity in this as well. The government didn't have a concrete way to regulate the internet boom of the 90's where hundreds of citizens made millions of dollars. I would assume they wouldn't want to pass up this opportunity to regulate the ‘new’ Wild Wild West. In my opinion, I do think they are making sure these applications are safe and accurate but on the back end, they see the cash like everyone else.”
Mike B.: “Tough to see smaller companies get drown out by the larger ones due to the fact that they do not have the funding to get past the FDA regulations.... might mean we miss out on ideas that can potentially improve our healthcare system.”
Jamien M.: “I think the FDA's exposure and the legitimacy that this exposure provides far outweighs the downside (barrier to entry, lack of innovation). In addition, eliminating the uncertainty that has surrounded this announcement is another plus that now enables companies to plan accordingly and develop with these guidelines in mind. The fact is, diagnostic tools, whether administered in office, or over an app, SHOULD be regulated--people rely on them for their well-being. I believe the definition of telemedicine will start to better come into focus because of this announcement. Communication, engagement and follow-up are all very ‘app friendly’ and generally won't fall under the FDA. Diagnostic tools will be much more scrutinized, as they should, and I think we all benefit from this.”
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