HIMSS Joins Partnership to Promote Quality Label for Health and Wellness Apps in Europe

HIMSS is partnering with 13 other organizations on a two-year project, titled Label2Enable, to promote a health app assessment framework and quality label in Europe.

The project builds on the work on the International Organization for Standardization/Technical Specification 82304–2 label, which defines requirements for good quality health and wellness apps that can be used by health professionals and patients.

Health app users currently lack the information they need to determine the quality and reliability of health apps. The objective of Label2Enable is to achieve Trust, Use and Adoption of an EU quality label for health apps.

HIMSS is among a group of partners cooperating on the Trust pillar, working to create and test the ISO/TS 82304-2 handbook for accredited health app assessment organisations. They will ensure the handbook contains appropriate assessment methodologies, aligns with EU legislation and values, produces the same consistent results regardless of the assessment organisation involved and works as well for app manufacturers.

This group will secure maintenance of the handbook after the project and enable accreditation of assessment organisations. They will also investigate if legislation for the label is sensible and who is to pay for the assessment.

For the Use pillar, consortium partners will investigate who consumers trust most to give them recommendations on health apps and what will also help people with low health literacy to use the quality label. They will find out what healthcare professionals need in the detailed app report to be able to recommend health apps and how to display the label effectively in app stores, app libraries and trusted sources.

Consortium partners working on the Adopt pillar will provide insights how to implement the ISO assessment framework effectively. They will explore with health insurers and health technology assessment bodies how the ISO assessment framework can help in decision-making on reimbursement of health apps.

Learn more about Label2Enable.