It has been a ground-breaking period for innovation and advances in the health care mobile app sector. Working on an acquisition attempt in 2003 by Medibuy Inc of the NHS data transfer framework brought my first taste of health sector technology. At that time the Internet, Intranets, Extranets and HTTPS – secure Hypertext Transfer Protocol were setting the new trends in health care technological innovation. Mobile Apps have long since taken over.
This article attempts to give a snapshot of the current new trends in health mobile apps and the applicable law. However, it should be noted that there are several complex legal implications arising from the fractured infrastructure and commercial realities of the sector. Apart from data protection there are issues of indemnities, product liability, or warranties, to name but a few.
According to the European Commission (EC), in 2015 there were around 100,000 health apps globally. The University of Illinois at Chicago website states that in 2010, consumers downloaded a 9 billion healthcare apps this was a statistic taken from the International Data Corporation. It also states that that figure was expected to reach nearly 77 billion by the end of 2014.
The following is a list of some of the most recent innovative health apps worldwide.
Happify New York, US
A happy thinking app for treating advanced depression. It is a particular favourite because it has so many cross applications across different sectors. It could be adapted to measure and treat stress at work for example. The app combats depression by assessing the lack of happiness among patients, and improving behavioural health using silver based advice and games. It has B2C and B2B versions. There is more information on their website.
Well Doc Inc., Baltimore MD US
The company launched a health app to monitor and manage type 2 diabetes. It is the first app of its kind to be cleared by the FDA for type 2 diabetes. They have called their prescription therapy Bluestar. They have done a deal recently with a Johnson & Johnson company to further commercialise the platform and app.
Ristcall, Philadelphia, PA US
The app helps hospitals and skilled nursing facilities to improve patient safety and satisfaction. It is an internet of things based innovation. It works on android based smart watches. The app provides real-time information about the health condition of patients reducing the need for patient attendance of nursing stations. Find out more.
MedAdvisor PVT LLC, Australia
The MedAdvisor app has improved prescription glaucoma medications. The app connects to planning dispensing systems and retained patient medication records. It’s health partner network includes BUPA
GiftedMom, Yaounde – Cameroon Africa
The GiftedMum app improves antenatal care particularly in developing countries in Africa and Asia. The app is designed to decrease the mortality rate by the provision of health information, vaccination tracking of children; and improving contraception techniques.
In order to decide on the applicable law, it is necessary to consider what the health app broadly does. If it is an app for medical purposes, then it falls under the regime of EU law as a medical device. Medical devices are subject to the European Medical Devices Directive (93/42/EEC – MDD) or the European In Vitro Diagnostic Medical Devices Directive (98/79/EC – IVDD). The law is under review.
There is some guidance on whether an app is for domestic or medical purposes in the Manual on Borderline and Classification in the Regulatory Framework issued by the European Working Group on Borderline and Classification.
Data protection relating to digital app technology also presents significant legal challenges for lawyers. The current legal framework is the Data Protection Directive (95/46/EC). There are ongoing talks regarding a uniform European General Data Protection Regulation. Learn more about the latest developments here. Given the UK’s imminent exit from the EU the UK legal data protection framework is even more uncertain.
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