Out-Law News | 14 Sep 2016 | 9:39 am | 1 min. read
The new App Store Review Guidelines, applicable from 1 September 2016, impose stricter standards on apps that behave in a way that "risks physical harm". They also incorporate stricter privacy rules for apps that handle health, fitness and medical data.
Drug dosage calculation apps are now limited to those developed by drug manufacturers, hospitals, universities and health insurance companies, or those that have received approval from a relevant regulator, according to the guidelines. Apps that could be used for diagnosis or treatment purposes "may be reviewed with greater scrutiny", with regulatory approval preferred, the guidelines state.
Apple has also banned applications that encourage "illegal or excessive consumption" of drugs or alcohol, consumption by minors, and the sale of marijuana, according to the guidelines.
Developers of apps that make use of health, fitness and medical data are now expressly prohibited from using or disclosing any of that data to third parties for advertising or "other use-based data mining purposes". An exception is provided for health management or research purposes, but only with permission from the user.
These apps are subject to higher standards of accuracy, and may not store users' personal health information on Apple's iCloud cloud-based storage system. Data may only be collected for the purposes of health-related human subject research if the project has been approved by "an independent ethics review board", and with the consent of the participants, according to the guidelines.
Victoria Bentley of Pinsent Masons, the law firm behind Out-Law.com, a patent law expert specialising in digital health, welcomed the new guidelines.
"We have become used to living in a world where there is an almost bewildering number of apps available in our daily lives, and where there are relatively few barriers to entry for developers," she said. "But where the health of patients is at stake, there is a greater need for regulation - given the implications if the information reported to a patient's healthcare team is inaccurate, or drug dosages are miscalculated."
"With this move by Apple, heath and wellness apps will be subject to greater scrutiny – giving consumers more reassurance that the ones they choose to download have come from reputable sources, and will have benefits for patients. They can also be reassured that those apps will be supported and updated when necessary," she said.
"As the potential for using apps and mobile devices in home health diagnostics and for patient monitoring increases across a wide range of health areas, the benefits for patients' well-being are hugely exciting," she said.