Policy and regulation for innovation in mHealth

  • Posted on 31.08.2012

Policy and regulation for innovation in mHealth

Jeanine Vos

Jeanine Vos

Executive Director, Mobile Health at GSMA


For the past two years, I have been working with great passion on the subject of mobile health (or mHealth), having set up the global mHealth programme of the GSMA – the organisation that represents the interests of mobile operators worldwide. I am therefore very pleased that the momentum for mHealth has really been building.

Governments and healthcare providers around the world are increasingly interested in the potential of mHealth to help reduce the cost of care and increase the reach of healthcare services offered. And the number of services is growing steadily. At the GSMA, we track service deployments around the world. I recently counted more than 800 mHealth services on our database, a hundred of which in Europe.

Nevertheless, mHealth is still quite removed from being a mass market solution. The GSMA is working in partnership with its members, the healthcare industry, end-user organisations and governments around the world to better understand their needs, the outcomes and impacts achieved, to see how we can catalyse this opportunity further to deliver sustainable and scalable mHealth solutions

When I talk to the key stakeholders around the world, they often mention that one of the key challenges to accelerate the adoption of mHealth is that of policy and regulation. Mobile health brings together healthcare and telecommunications industries, which both have specific policy and regulatory environments. This raises questions and uncertainties, such as, how do medical device regulations apply to mobile health solutions? How can existing legislation for data protection in telecom networks be translated into a healthcare setting? How will mobile solutions be reimbursed?

Nonetheless, I would like to provide a more positive perspective in the efforts of combining these needs. There is a great opportunity here; we can learn from each other and together, based on expertise and best practices across both sectors, develop appropriate policy and regulatory approaches that suit a fast-evolving world, in which patient safety and patient trust are the cornerstones.

To provide a couple of examples of key subject areas. The real strength of many mobile health solutions is that they empower individuals to manage their health more effectively. Policies and regulations should therefore support patient empowerment, and provide the patient control of their health data. Reimbursement should evolve to incentivise positive health outcomes, not only reward treatments. Medical device regulation is essential to ensure patient safety, and further clarity should therefore be provided as to how it applies to mobile health solutions. Interoperability and common standards should be promoted, to enable scale and offer the convenience of plug-and-play solutions.

Current and upcoming debates at EU level around regulatory frameworks for data protection and medical devices offer an important opportunity in this respect, to exchange views and enhance clarity in regulatory frameworks that enable the implementation of mHealth solutions across the EU.

I look forward to discussing these subjects in more detail with you at the European MedTech forum, for a panel discussion on the topic of “Innovation-friendly policy to improve mHealth uptake”. It will be held on the afternoon of October 10 and I will be joined by Bastian Hauck, a diabetes patient and industry representative. We will provide an overview of which changes could be implemented in the policy and regulation arena to improve mHealth update, but also discuss the perspective of patients and industry in order to understand the day-to-day reality of mHealth.

Jeanine Vos, Executive Director, Mobile Health at GSMA

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