Apple research apps to require ethics board approval
pharmafile | April 30, 2015 | News story | Sales and Marketing | Apple, BMJ, FDA, GP, researchkit
New guidelines will require apps developed for Apple’s ResearchKit health platform to be approved by an independent ethics board.
The ResearchKit software offering lets people volunteer to join medical research studies conducted via apps that use iPhone sensors to gather patient data on a variety of diseases – for example tapping on the screen in a rhythm to test for Parkinson’s disease.
Two weeks after its launch, though, Apple has updated its guidelines to state: “Apps conducting health-related human subject research must secure approval from an independent ethics review board. Proof of such approval must be provided upon request.”
Apple previously updated the guidelines shortly after the first ResearchKit software was launched to say that they all must obtain explicit consent from participants. They must also provide information about the context of the research, as well as any risks that might come with it.
The apps currently available through the platform already conform to all these guidelines, but it is too early to tell how it might affect the development of further software.
This is part of a trend towards increased regulation and validation of the growing personal health technology market. In the UK, the NHS is planning to introduce a ‘kitemark’ to show which apps have been validated by the health service, while in the US the FDA has released draft guidance on how wearable health tech devices should be regulated.
The draft guidance says that ‘general wellness devices’ designed to maintain or encourage a healthy lifestyle do not need to be regulated, but devices that could pose a risk to patients’ safety if they do not function properly may need to be.
The risks of medical software were highlighted recently by GP and medical commentator Des Spence in an article for the BMJ. Spence argues that although most health apps are ‘mostly harmless and mostly useless’, those that monitor things like heart rate and blood pressure could be could actually cause ‘medical harm’ and ‘ignite extreme anxiety’.
He says that this is because they are untested and unscientific, and play on the fears of an ‘unhealthily health-obsessed generation’ through over diagnosis of health conditions.
Spence adds that medical technologies are already overused for magnetic resonance imaging and blood tests and “we should be sceptical of more medical technology”.
So far ResearchKit appears to have had some success – 11,000 people were reported to have signed up for Stanford University’s cardiovascular study based on the platform within 24 hours.
George Underwood
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