Out-Law News 2 min. read

Mobile health rule writers must protect privacy and security without stifling innovation, says expert

New products and services in the mobile health (m-health) industry must not be made subject to overly strict new rules or guidance, an expert has said.

Specialist in digital health regulation Alison Ross Eckford of Pinsent Masons, the law firm behind Out-Law.com, said, though, that stiff privacy protections and security requirements are necessary to win consumers' trust, improve the adoption of m-health solutions and ultimately cut the cost of delivering health care.

Ross Eckford was commenting after the European Commission published the responses to a consultation it held on m-health last year. "A strong majority" of respondents said "strong privacy and security principles" for m-health are necessary "to build users' trust", according to a summary of the responses (31-page / 755KB PDF) published by the Commission. Many respondents also flagged the need for interoperability of m-health solutions and clarity on what m-health app developers are liable for, as well as the potential for new certification schemes to help ensure m-health solutions are safe for patients.

The Commission said it would look at all the "proposed actions" the consultation responses have called for and set out its intended "policy responses" later this year.

"The consultation results confirm what we already knew to be the key areas of concern for public authorities, healthcare providers, patients’ organisations and entrepreneurs – privacy, safety, and cost," Ross Eckford said. "The value of the consultation results lies in the fact that these key messages have now been officially communicated to the European Commission with common voice."

"There is clearly a need for increased guidance and legislative schemes in order to clarify the regulatory framework around m-health, since developers of m-health solutions need to be aware of their liability whilst users need to trust in solutions which are using and sharing their health data. Regardless of the form that takes, whether guidance, legislation, code of conduct, certifications schemes, as ever, it needs to be balanced against the potential for over-regulation and the stifling of innovation," she said.

Ross Eckford said the recent negotiations on new EU rules on the regulation of medical devices had highlighted the difficulty of "developing effective legislation which can support solutions getting to market quickly and effectively whilst ensuring consumer safety".

Respondents to the Commission's consultation said there are lessons to be learned in the EU from the way other countries have approached issues relating to m-health.

Ross Eckford said the US Food and Drug Administration (FDA) is recognised as being "ahead of the game" since it has already issued guidance on m-health matters, including in relation to privacy and development.

"The consultation results indicate that there is much the Commission can learn from the US regulatory regime and examples of best practice," the expert said.

In its consultation, the Commission had acknowledged that there are issues to resolve around how m-health solutions should be paid for. Some respondents called for reimbursement models to be reconfigured to allow health care providers using m-health solutions to receive a cut of any efficiency savings stemming from their use. Other respondents said m-health services should be paid "made available and funded as part of standard healthcare services provision".

"Cost is the over-riding factor in m-health development and implementation," Ross Eckford said. "In the consultation results, funding and reimbursement schemes were considered one of the top policy tools required for the delivery of interoperable m-health services. It’s important that m-health can be shown to deliver health outcomes and efficiency improvements and the consultation results rightly underline the need for funding and reimbursement schemes to reward those outcomes and provide further stimulus."

Ross Eckford said businesses can expect to get a better insight into the Commission's own approach to m-health issues when it details its policy proposals.

"Given the rapid pace of m-health development and the urgent need for regulatory clarification in the all-too grey arena of m-health, the industry, authorities and patients will look forward to the Commission's policy publications as they will provide a clearer indication of the Commission’s own stance," she said.

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