OBJECTIVES: eHealth solutions may enhance healthcare management and reduce costs. Since regulatory frameworks usually determine funding pathways, the aim of this study was to assess the potential impact of current and future eHealth-related changes to regulatory frameworks in the European Union (EU) and the United States (US) on funding of different types of eHealth technologies.

METHODS: A targeted literature review was performed in Medline and Embase, complemented by ad-hoc and primary search with country eHealth experts and payers.

RESULTS: The claimed medical purpose of the eHealth solution determines its assessment by regulatory bodies while lifestyle/wellbeing solutions do not follow specific regulatory paths. Classification could also affect potential coverage, since it may only be applicable to approved medical devices.

In response to expansion of mobile health applications, some health authorities and independent organisations have developed good practice guidelines for manufacturers and evaluators, or technical and clinical reviews to allow ranking applications and positioning in dedicated libraries.

Generally, eHealth solutions with specific medical claims or combined with drugs follow the regulatory path of medical devices and/or drugs. Recently, changes were introduced to regulatory frameworks for medical devices in the US and EU. Following modification of the medical device definition, some software solutions are no longer classified as medical devices in the US. Those which still classify could be evaluated under a new, flexible pre-certification pilot program, aimed to assess manufacturers instead of solutions. In the EU, with the release of new medical device regulations, stricter rules on device classification and evaluation were introduced.

CONCLUSIONS: Regulatory classification of eHealth solutions along with identified regulatory changes are expected to impact eHealth potential market access. More flexible approaches in the US may accelerate the adoption of eHealth solutions, while stricter EU regulations raise hurdles before launch. Nevertheless, evidence generated for authorisation may facilitate adoption by HTA bodies and payers.