Should software be licensed as a medical product?

Increasingly software is being used not only for controlling hardware (whether it be medical imaging machinery, dialysis pumps or pacemakers), but is used in and of itself in the health and medicine space.

So pedometers on mobile phones for tracking activity, dietary trackers and advisors, exercise plans...

Many users download these apps onto mobiles and tablets, and use them to inform lifestyle choices which can have serious medical implications.

Should software in this kind of area be more closely regulated, or would this "stifle innovation" and "restrict choice"?

Posted by Stuart Andrew Adamson on 18th Jan 2017
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Comments (3)

Andrew Simpson

10 November 2017

There is a EU Regulation named the Medical Device Regulation which all software companies / Health Care trusts who are involved in the creation of software as a medical device, must adhere to.

The idea is that software is to be CE marked, and I believe there will be an central authority issuing unique identification numbers for software like this.

Mike Broomhead

01 April 2017

Part of the challenge is agility -- for a "learning health system" to be up-to-date.

We know there are systems deployed with unaccurate algorithms right now . . .

Regulation as-is prevents easy maintenance. We should look at how other industries have tackled comparable challenges where trust / accuracy are important.

Gareth John Baxendale

23 January 2017

This is really interesting area as increasingly patients are essentially self-prescribing themselves apps for all manner of clinical conditions from sleep monitoring, managing diabetes and mental health issues.

The major concern is where a negative outcome occurs due to the use of such apps, who would be responsible? MHRA and NICE are all working to solve how best to regulate these but not much has been forthcoming.

Almost all apps are unregulated and state that they are "not a medical device" yet patients are using them so the demand clearly necessitates some form of regulation.

GP's would feel more comfortable prescribing an app if it had the right level of regulation... that 'right level' is a topic in itself!