Regulation of mHealth apps – let the debate begin
imedicalapps has reported that Apple may be starting to impose tighter restrictions on the approval of mHealth apps through the iTunes store. This follows on the appropriate oversight of the uCheck urine analyzer application (a way for automated reading of urine dipsticks).
The implication of the report is that Apple will only accept medicines information that is endorsed by the manufacturer of the medicine. Whilst this is a liability issue for Apple in some respects it is also fair guidance although one would argue that endorsement of the manufacturer might simply constitute dissemination of medicines information in accordance with the approved Product Information (PI) rather than written endorsement by the manufacturer.
Whilst such an approach is in keeping with law in actual medical practice a large number of medications are used according to valid evidence but outside information in the PI, also known as ‘the label’.
There is an urgency for a public debate about the best way to deal with this issue. Given the number of apps already in existence and the number of medications it is not likely that a regulator or an individual company has the resources to review everything in a timely fashion. The best approach might be to pursue (international) standards as proposed by organisations such as Happtique rather than a draconian regulatory approach.
Just as the NSA scandal has revealed the level of involvement of IT companies in our day to day lives we must also remember that these companies….Apple, Samsung, Google, etc, are now also the largest healthcare providers and the main conduits for health information both for practitioners and patients.