A Balance of Regulation and Innovation Necessary for Continued mHealth Development

The European Commission released results from its consultation on mHealth on January 14. Several interrelated themes emerged from the analysis of comments from the 211 respondents (71% were from organizations and 29% were from individuals). Overall, respondents felt that the success of an mHealth concept is based on its capacity to generate trust from a wide range of users.

Data Protection

Respondents felt that health data is sensitive, and that privacy concerns should be taken into account throughout the lifetime of an mHealth product or service. App developers should only collect, process, and store personal data if it is absolutely necessary, according to respondents.

The need for clear governance structures to promote the public’s trust of big data was considered key, as was the need to make distinctions in data protection levels depending on the mHealth service’s purpose.

Interoperability

Respondents highlighted the need to share data from mHealth apps with electronic health records (EHRs) via increased interoperability. Interoperability with EHRs was deemed important to ensure the continuity of care, to increase patient education and empowerment, and to facilitate research.

The Big Data Tightrope

A middle ground must be sought for big data regulations, which should ensure a patient’s privacy without incurring additional cost burdens for developers. The certification of mHealth applications through a governing board was the most commonly mentioned method to ensure patient privacy.

Some respondents warned against over-regulating the mHealth space, however, as the additional costs might discourage innovation. While some respondents offered stripping identifiers from data as another solution, others warned that anonymization could render a dataset useless in certain research situations.

As the EU considers possible mHealth regulations or best practice guidelines, further discussions about the definition of health data will be helpful. For example, are height, weight, activity levels, and calorie intake considered health data? Would these inputs require the same protections as habitual behavior tracking (i.e., drinking, smoking, or exercise)? Should mHealth developers feel more or less responsible for ensuring the privacy of these data points than, say, a patient’s medical diagnosis?

Policy Issues

Funding and reimbursement, public education and awareness, and quality were the most frequently anticipated EU and national policy measures, which—if implemented—might support equal access to healthcare for all.

The strongest case for mHealth development is its potential to reduce healthcare costs and improve population health. However, before mHealth can be adopted, both patients and providers will need to better understand the potential value of mHealth. This will require increased health and ICT literacy, as well as reimbursement structures for preventive medicine and telehealth.

Research

Certain challenges—like the dearth of scientific evidence of mHealth’s efficacy—exist that should take precedence in policy discussions. When questioned about the availability of evidence to support the uptake of mHealth, more than half of the respondents either did not provide an answer or indicated that there was no, or little, evidence.

Quantitative research is needed to explore cost-effectiveness, business models, health economics, outcomes, integration issues, and new ways to measure clinical outcomes. Research to assess mHealth’s impact on behavior change and potential usefulness among vulnerable populations and those with disabilities would also help policymakers, physicians, developers, and investors to better understand this dynamic industry.

Who Is Liable?

The need for app developers to have a clear understanding of their liability when designing mHealth solutions is considered to be crucial. Discussing who is liable—and to what extent—for mHealth-related complications is an important concern.

Respondents to the European Commission’s questionnaire felt that, for mHealth solutions that provide medical information, verification by a health professional should be mandatory. If this were the case, healthcare providers would require adequate mHealth training.

A handful of respondents also felt that mHealth applications should clearly state that the information provided is supplementary, and should not replace diagnosis by a physician.

International Cooperation

While respondents felt that mHealth solutions were most likely regional solutions, several respondents highlighted the need for the adoption of international standards or guidelines covering the development of adequate security and privacy mechanisms for mHealth. International insight might also be vital to ethical discussions in mHealth.

Respondents indicated the EU could learn valuable lessons on mHealth innovation from low to medium income countries (e.g., China) as well as some African countries—where the deployment of mHealth services is increasing access to healthcare for rural communities.

Market Access

Both building a platform for exchanging experiences and also enhancing cooperation between different stakeholders were seen as important tools to stimulate the involvement of industry and entrepreneurs in mHealth. Respondents also mentioned knowledge barriers and difficulty assessing medical expertise as impediments to getting solutions to market.

What’s Next?

After assessing the proposed solutions, the Commission will present a set of policy responses later this year. The Commission will work with member states and countries outside the EU to strengthen international cooperation, and intends to support further mHealth deployment under Horizon 2020.

Jenn Lonzer has a B.A. in English from Cleveland State University and an M.A. in Health Communication from Johns Hopkins University. Passionate about access to care and social justice issues, Jenn writes on global digital health developments, research, and trends. Follow Jenn on Twitter @jnnprater3.