Health Transformation Blog
What is a medical device? In MEDDEV The EU Commission try to sort this thing out. It is not easy, according to the rules, to know the borderlines.
In Sweden the Medical Product Agency just released a document proposing how to classify software in healthcare.
This report has the conclusion that software, direct or indirect, built to influence diagnose, care and treatment of a single patient must be regulated under a product safety framework. The authors have not found any other suitable framework than the one for Medical Device.
The tree directives in EU are:
o Active Implantable Medical Devices Directive (AIMDD)
Directive 90/385/EEC – OJ L189/ 20.7.90,
o Medical Devices Directive (MDD)
Directive 93/42/EEC – OJ 169/ 12.7.93
o In Vitro Diagnostic Medical Devices Directive (IVDD)
Directive 98/79/EC – OJ331/ 7.12.98
Standards helping along the path include ISO 14971, IEC/TR 80002, IEC 60601, IEC 62304 and IEC 62366.
Software used in healthcare is a “product” according to the authors. They think that it must be looked upon as a product and terms like “project”, “service” etc must not be used describing a medical information system. If you see it this way, the Medical Device Framework is ready to use. The authors see in the future that medical software, not CE marked, should not be chosen in public purchase.
Is this a feasible path?
About the author
Krister,
Thanks for highlighting this work in Sweden. Interesting semantics. Can a healthcare software “product” be run as a [managed] service? Is the intention to create a set of software products that conform to a standard ontology, set of clinical terminologies, processes etc, or to create a product that has some independent level of “quality” [clinically safe?] assurance?
Is it known which aspects of the software “product” will warrant scrutiny and assessment? Is it process and outcome, is it a detailed review of the internal data model and mappings within the product (I’m sure software vendors will be delighted to expose what they typically see as a core USP), is it all of the above and more?
If they follow the devices directives approach, then I imagine this will be wrapped up in a conformity declaration – so it will be interesting to see what the product must conform to. That will determine the benefit…and the cost to be borne by the software vendors.
Without several years of evolution and development (which in itself may create conformity issues) I’m struggling to see how this will add sufficient value to make it worthwhile. I’d love to be proven wrong however.
Please keep us posted on how this develops.
Jason, thanks for your input!
I think it it a long and tricky road to meet the goal. I keep you posted!
thanks