Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in POLITICO Morning eHealth, in “Dexcom Talks More About Alerts Outage,” by Mohana Ravindranath.
Following is an excerpt:
The outage afflicting the “follows” feature of Dexcom’s continuous glucose monitoring system — which allows caregivers to stay apprised of patients’ blood sugar levels — was an unusual event not previously tested, Jake Leach, the firm’s chief technology officer, told Morning eHealth.
Dexcom’s follows feature gives caregivers (often parents of diabetic children) important updates about how a patient is doing. If the app stops working — particularly without users being aware of it, as happened in the outage over the weekend — it’s a potentially dangerous situation.
The feature relies on the cloud. Leach said the outage occurred because too much traffic snarled Dexcom’s cloud systems, even though the firm had extensively stress-tested its infrastructure — both in the normal course of events and in submissions to the FDA. The problem was that the traffic was “internal to the cloud,” Leach said, rather than additional requests from actual users.
“If you look at the growth of our customer base — one of the things we ensure is that we have significantly have more capacity than customers,” he said.
With health tech becoming increasingly connected, cloud outages are something companies and the FDA will have to keep its eyes on. Bradley Merrill Thompson, an attorney at Epstein Becker Green who specializes in FDA issues, said the agency is generally aware of the dangers and encourages firms to build in safeguards — a “belt and suspenders” type of redundant system — or provide warnings that products might not be connected at all times.
