Although my fellow editor Chrys has done a great job of covering the Ofcom-sponsored report on attitudes and behaviours of apps users, and The Boss (aka Donna) has highlighted the HIMSS Analytics Mobile Study as well as covering the opposition to the PROTECT legislation, identifying a tax issue that might just be behind it all, there is still more to report on the apps front this week.
Beginning with that PROTECT legislation, the same Brad Thompson that Donna quotes also writes in Mobihealthnews of the recommendations of the FDASIA committee on how the FDA can improve the regulation of mobile health. The overall recommendation is that the “FDA needs to do a better job at a very granular level of explaining what types of software the agency regulates and what types it doesn’t. The examples of topics given at the FDASIA workgroup where FDA needs to provide greater clarity as soon as possible include:
- The difference between disease-related claims that FDA regulates and wellness related claims that the agency does not.
- The circumstances under which software is considered to be an accessory to a medical device, and thus regulated.
- The definition of clinical decision support software, and the types of such software that are high risk and thus merit regulation.”
He goes on to explain the importance of knowing whether the FDA will regulate an app in determining the investment business case: uncertainty discourages progress. Further FDASIA recommendations are that “for those apps that FDA does regulate, the agency needs to do a better job at a detailed level of explaining how the following requirements apply to mobile apps:
- The regulatory pathway for premarket review,
- The quality system requirements and
- Post-market obligations including adverse event reporting.”
I particularly like the distinction drawn between disease-related and wellness-related apps which gives greater precision to the debate. Well worth a detailed read.
Observant and loyal TTA readers will spot that the problems identified, and solutions offered very much mirror those of my own TSB-funded activity of the UK medical app regulatory scene covered previously in Telecareaware.
So what is the attitude of doctors to apps in the US? A survey of 1500 doctors reported in FierceMobileHealthcare indicated that 37% have prescribed a mobile medical application to their patients. The article goes on to report an additional survey of 250 doctors that found:
- 42% won’t prescribe apps because there is no regulatory oversight of them
- 37% have no idea what apps are out there
- 21% never recommend apps to patients
- 21% won’t prescribe apps because there’s no longitudinal data on apps’ effectiveness
- Another 21 % won’t prescribe apps because it would generate an overwhelming amount of patient data
All the above very much support both the FDASIA recommendations and indeed echo those I produced for the UK – in particular the proposal that the remit of NICE be extended to cover medical apps is particularly key to overcoming concerns about effectiveness in the UK, and indeed to the issue also mentioned in the same article of being able to compare the effectiveness of apps and drugs, wherhe the two are both considered able to provide effective treatment (eg for depression or anxiety).
Setting the scene in the EU is Neelie Kroes who produced a great, short, video on the importance of health-related apps as part of the revolution in the delivery of healthcare. This is to trail the arrival of the EC’s Green Paper on the topic due out in a month, and on which comments will be invited from all.
Finally, an interesting item on the growth in employment in the apps economy in Canada – doubtless echoed elsewhere. Although, other than a comparative ‘focus’ bar chart, there is no breakout of health and wellness-related employment, healthcare gets many mentions. Clearly this is a sector that will become increasingly importance, and therefore in need of support with regulatory certainty.
Hat tip to Prof Mike Short for the Neelie Kroes video and the Canadian study.