Labelling of health apps: building on lessons learnt from the European energy, food and medicine labelling schemes


June 13, 2024

The Label2Enable project is developing a certification scheme for taking CEN-ISO/TS 82304-2:Health software

Part 2: Health and wellness apps — Quality and reliability[1] from a Technical Specification to EU level label which could be used similarly to existing consumer quality and information labels used for electrical goods and food. The project team analysed the existing legislation on the EU energy label, the front-of-pack nutrition labels and the European Medicines Agency’s packaging label for medicines for human use to provide a baseline of understanding on which the Label2Enable initiative can build.

Given that the CEN-ISO/TS 82304-2 was inspired by the EU energy label, the Nutri-Score front-of-pack nutrition label and the FDA over-the-counter medicine label, we wanted to explore what we can learn from what is "behind” these labelling schemes. Focusing on the EU policy and legislative landscape, we looked closely at Regulation (EU) 2017/1369 setting a framework for energy labelling, Regulation (EU) 1169/2011 on the provision of food information to consumers, and Directive 2001/83/EC on the Community code relating to medicinal products for human use as well as the legal and practical solutions related to their implementation. Findings resulting from desktop research were presented and discussed with a wide range of stakeholders during the Label2Enable workshops.

Key findings in relation to applying learnings from other labels to health and wellness apps include:

· Earning and maintaining the trust of consumers and industry is a long process. For a label to be effective, it needs to be in plain sight, attract attention and then be accepted and understood by the consumers before it can potentially influence their choices.

· Familiarity with the label is key to its acceptance, and should be fostered in users of health and wellness apps through education and engagement actions that target both users and potential prescribers of apps.

· Stakeholder engagement is key, consumers and providers must be at the heart of the process for the development of labels. With respect to labelling of health and wellness apps as trustworthy, accurate, easy to use, secure and effective, this demands that citizens, healthcare professionals and payors are involved, not just as users but as co-creators of labels.

· Certification by expert third party organisations is central to building trust. Statutory and commercial certification bodies that involve stakeholders through design and maintenance of the scheme are considered by Label2Enable stakeholders as vital factors to build trust. Energy and front-of-pack nutrition labelling are based on self-assessment/certification, while medication labelling is third party certification, reflecting the risk of medication misuse on health.

· As labels provide a highly visual representation of key information, it is important that in addition to the labels, health and wellness apps are equipped with accompanying adequate documentation that helps healthcare professionals to recommend apps and insurers to decide on reimbursement, as well as there is a need for a depository to locate details of certified apps.

· Given that health and wellness apps can have a direct impact on a citizen’s health and yet in many cases are also obtained without the intermediation of a healthcare professional, stakeholders have indicated they would welcome the rigour and certainty of a label underpinned by EU legislation, similar to medicines labelling, and the EU flag on the label, similar to the EU energy label as a trust-adding factor.

·  All three labels researched became mandatory overtimeStakeholders participating at the Label2Enable workshop shared support for a gradual approach to make quality labelling of health and wellness apps mandatory.

We concluded that until EU level support in the form of legislation is secured, national level initiatives could provide test beds for the introduction of the CEN-ISO/TS 82304-2 label. This could build on the fact that Member States are increasingly interested in implementing assessment schemes beyond CE marking to bring health and wellness apps into the range of healthcare services that may be prescribed by healthcare professionals and reimbursed by statutory health insurance schemes. Furthermore, CEN-ISO/TS 82304 could provide valuable input into developing the labels provided for in the European Health Data Space (EHDS) Regulation, and other future EU labels.

The analysis was done by Petra Wilson and Anett Molnar from HIMSS.

The respective deliverable will be made available on the project’s website following the approval of the granting authority.

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