Consultation launched on mobile health but expert says guidance for organisations needed now

Out-Law News | 10 Apr 2014 | 5:22 pm | 3 min. read

Organisations need more guidance now on how to address some of the legal challenges with developing or implementing mobile health (m-health) solutions, an expert has said.

Digital health expert Indradeep Bhattacharya of Pinsent Masons, the law firm behind Out-Law.com, welcomed the European Commission's new green paper consultation on m-health (20-page / 156KB PDF) but said that m-health is transforming the healthcare landscape now and so greater guidance is needed more urgently.

"M-health is in action at the moment and it is radically changing how consumers and patients access healthcare services," Bhattacharya said. "It is important that, for patient safety and to ensure businesses have a clear path for delivering innovative new products and services, there is guidance issued soon to help businesses overcome the myriad of challenges present in providing m-health solutions. This is also essential to ensure the devices hitting the market are safe and patient's rights are protected."

"M-health innovation within the EU risks falling behind other jurisdictions if organisations are left to manage these issues alone. In the US, for example, the Food and Drug Administration (FDA) has already issued guidance on mobile health app development, and there is ongoing dialogue about health data privacy and device safety in an m-health context," he added.

The Commission's consultation recognised that a range of commercial, legal and regulatory issues arise in either supplying or implementing m-health products and services.

It highlighted data privacy issues and the phenomenon of big data and how that interplays with m-health solutions, and also identified that the rollout of innovative new m-health products and services has a potential impact on patient safety, and that it raises issues of liability for manufacturers and health care professionals. It further acknowledged that there is an issue to resolve around how m-health solutions should be paid for.

The Commission said that the rise in the number of lifestyle and wellbeing mobile applications had resulted in a blurring of distinction between the provision of health care and the "self-administration of care and wellbeing".

With that blurring in mind, it has asked for views on whether the EU's legal framework adequately covers "safety and performance requirements of lifestyle and wellbeing apps" and whether regulators' enforcement powers need to be strengthened to ensure patient safety.

It said that concern for the safety of m-health solutions and of lifestyle and wellbeing mobile apps may well explain a lack of trust among sections of the public about m-health and its benefits.

It said that there are some existing initiatives designed to address some of the concerns, including within the UK NHS where a certification scheme vets mobile apps for safety and compliance with data protection laws. However, the Commission has asked whether there is specific "policy action" needed to address the concerns further and "ensure/verify the efficacy of m-health solutions".

The Commission also asked for industry's views on whether there are any "specific security safeguards" that could be included with m-health products or services to "prevent unnecessary and unauthorised processing of health data". It also is seeking views on how mobile app developers can "best implement the principles of 'data minimisation' and of 'data protection by design', and 'data protection by default' in m-health apps".

The green paper has also asked for views on how to help m-health manufacturers and health care professionals "mitigate the risks" inherent in the use and prescription of m-health products and services, as well as on whether there are any good practices in incentivising and refunding businesses that provide m-health solutions.

It also recognised the importance of standards in m-health and asked what the Commission can do to help ensure different m-health systems are interoperable.

The Commission said that wide adoption of m-health services across the EU depends largely on improving mobile internet services and connectivity. It asked what policy action should be taken to "support equal access and accessibility to healthcare via m-health".

"The green paper recognises the commercial reality of m-health and digital health generally as a phenomenon that is taking over," Bhattacharya said. "It identifies some of the challenges that exist from the perspective of industry, regulators and consumers and the Commission has recognised that there is limited guidance at the moment from a regulatory and legal stand point."

"The Commission pointed to issues that will define what happens in the digital health space, from data protection in the big data age to patient safety requirements and the interoperability of systems. It does not reveal its own thinking on these issues, but some of the issues are within the Commission's gift to influence, such as how new EU data protection laws that are currently under consideration account for the processing of health data," the expert added.

"However, some factors influencing the extent to which m-health can take off are dependent largely on national policies and politics, such as how m-health is integrated within national health services across the EU and, ultimately, how the cost of providing m-health is paid for and by whom. Industry should participate in the consultation to help frame the debate on these issues," he said.

Responses to the Commission's consultation can be submitted up until 3 July.