Happtique, an appstore for mobile medical devices has drafted an
App Certification Program.
This not a program or a process but a list of functional and non functional
requirements that mobile health apps should respect to be certified - according
to Happtique. It' a bit like the requirements of Apple to be authorized to
place an app in the Apple Store. Happtique publishes your app on its store if
you are compliant with its certification program.
There is a lot of work behind this document, and a lot of knowledge. However I
don't think this is enough to make a certification program. This document
focuses on the results, whereas all software development standards focus on the
processes. FDA focuses also on the processes when its auditors verify
compliance to 21.CFR.
In the scale of precedence of documents, I would put it here:
- Legal (choose your country): 21.CFR, 92/42 EEC (essential requirements),
CMDCAS, ANVISA, KFDA...
- Medical devices general standards ISO 13485 and ISO 14971
- Software development standards: IEC 62304, IEC 60601-1, and the like
- Guidances: GPSV, IEC/TR 80002-1, ISO/TS 14969
- Generic functional and non functional requirements: Happtique App
It's obvious that Happtique wants to make some noise with its certification
program (and it has reached his goal, you're reading this post). But I have to
recognize that this document contains a big source of information for software
requirements. The content of this certification program is a perfect source of
ideas to write a software requirements specification (SRS).
The world of mHealth is moving fast. In the same kind of article, I have found
Barbarians at the Medtech Gates, this article is a good summary of
antagonist forces at stake. On the one hand, the regulators and their, so
called, ante-Flood rules. On the other hand, the software industry with its new
world of mHealth. Guess who's going to have the last word? If, like me, you
don't have the answer, continue to apply the standards and regulations...