In early March 2024, EU legislators reached an agreement on the European Health Data Space (EHDS). For now, we only have a working draft version of the text, but many interesting points have already been highlighted. This article focuses on “wellness applications” and their impact on medical devices. For an overview of EHDS, see the first post in this series.
The final EHDS document was adopted by the European Parliament on 24 April 2024 and will be formally adopted by the European Council in the coming months.
1: Wellness applications and medical devices related to electronic health records
a) Wellness application
The EHDS includes certain provisions regarding “wellness applications” that claim interoperability with electronic health records (“EHRs”). In his original EHDS proposal, published in May 2022, “wellness applications” were defined as:
“Equipment or software intended by its manufacturer to be used by natural persons to process electronic health data” For non-medical purposesThings like happiness and the pursuit of a healthy lifestyle. ” (emphasis added)
The latest draft of the EHDS defines the term more broadly:
“Equipment or software intended by its manufacturer to be used by natural persons to process electronic health data” In particular, to provide you with personal health information; or Providing care for purposes other than providing medical care. ” (emphasis added)
Wellness applications that claim interoperability with an EHR system in relation to harmonized components of the EHR system (and thus comply with the mandatory requirements and applicable common specifications) may be brought to market (as are EHR systems). A “digital test environment'' will be made available by the European Commission or Member States to evaluate harmonized components of the application before application.
Assuming the test results are positive, manufacturers will need to apply (digital) labels to their wellness applications to inform users of their interoperability and effectiveness. Labels are issued by the manufacturer and are valid for up to three years. The format and content of the label is determined by the European Commission.
Wellness application interoperability does not imply automatic transfer of data to a user's EHR. Such sharing will only occur with your consent. The user must also have the technical ability to decide which parts of the data to insert into her EHR and under what circumstances.
Finally, manufacturers of labeled wellness applications must register their applications containing test environment results in the EU database maintained and published by the European Commission.
b) Medical equipment
- interoperability
The EHDS also affects medical devices, but the EHDS definition and current draft law are open to interpretation when it comes to defining these obligations. First, the revised definition of “wellness application” now appears to cover devices and software that provide information about an individual's health, and may be broad enough to encompass medical devices. There is. or Providing care for purposes other than providing medical care. Depending on how you read it, “purposes other than the provision of health care” does not necessarily limit both of the aforementioned elements of the definition. Additionally, the definition of “EHR system” (electronic health record system) is very broad and includes any “appliance or software.” Both of these definitions may include medical devices.
Similar to the position of health applications, medical devices and IVDs that claim interoperability with harmonized components of EHR systems areDemonstrate compliance with the mandatory requirements for the European Interoperability Component of EHR Systems and the European Logging Component of EHR Systems. ” Specified in Appendix II Section 2 of the EHDS.
Mandatory EHDS interoperability requirements apply only to the extent that manufacturers of medical devices/IVDs that provide electronic health data processed as part of an EHR system claim interoperability with the EHR system. In this case, the provisions of the “common specifications” for EHR systems should also apply to those medical devices.
- Conformity assessment
The EHDS announcement certifies that certain components of EHR systems are medical devices and is subject to the Medical Device Regulation (EU) 2017/745 (“MDR”) or in vitro Diagnostic Regulation (EU) 2017/746 (“IVDR”).
As specified in Recital 29 of the EHDS, software or modules of software that are medical devices, IVDs, or high-risk AI systems must be certified in accordance with the MDR, IVDR, and AI laws, as applicable. Imagine a medical device that: (1) medical devices, (2) stores or displays electronic medical records, (3) accomplishes the medical device's intended purpose, and (4) uses AI for data processing. This hypothetical product is certified as a medical device and EHR system, and also uses AI to accomplish the device's intended purpose. Manufacturers are therefore required to carry out conformity assessments based on (at least) three different EU regulations: (1) the MDR, (2) the AI Act, and (3) the EHDS Regulation.
In such a case, “[w]Here, EHR systems are subject to other European Union legislation regarding aspects not covered by this Regulation and also require an EU declaration of conformity by the manufacturer…, There shall be a single EU declaration of conformity for all EU laws. Applicable to EHR systems”
In order to limit the administrative burden on manufacturers, the EHDS requires EU member states to take appropriate measures to ensure that their respective conformity assessments are carried out as joint or coordinated procedures. However, it will be interesting to see how EU member states achieve this. This is actually. Experience has shown that this does not work for (single) conformity assessment based on MDR…
- Registration
There also appear to be inconsistencies in the latest draft EHDS regarding registration requirements for medical devices. Article 32(3) EHDS suggests that medical devices that also qualify as EHR systems or claim interoperability with EHR systems should be registered under the new 'Medical Devices' category.EU database for registering EHR systems and wellness applications” In addition to registration under the Medical Device Regulations (In other words, registered with EUDAMED). However, Recital 36 EHDS contradicts itself and suggests that the new registration obligation only applies to “.EHR systems and wellness applications; not falling within the scope of Regulation (EU) 2017/745, and […] [AI act COM/2021/206 final]…” for medical equipment “Registration must be maintained in an existing database…”
The EU appears to be facing significant challenges with large-scale IT projects such as an EU-wide database (for exampleEUDAMED, CTIS), and in any case it remains to be seen whether the new EU database for the registration of EHR systems and wellness applications based on the EHDS will be operational in time to support the implementation of the EHDS.
2: Secondary use
The EHDS sets out a long list of eligible electronic health data that should be made available for secondary use under the EHDS. This includes data from wellness applications and health data from medical devices, among others. Note that this chapter of the EHDS is not limited to wellness applications or medical devices that claim interoperability with EHRs.It seems to apply to all Wellness applications and medical equipment. Data owners of data generated by wellness applications and devices (see this blog for more information) must share this data upon request from HDAB.
However, Member States appear to be allowed to introduce stricter safeguards (such as opt-in consent) for the reuse of health data from wellness applications based on EHDS, but not from interoperable EHR systems. Please note that health data is not allowed. Health data from medical devices can be used or derived from health data from medical devices. This makes little sense, but it will be interesting to see what safeguards (if any) Member States actually put in place.
We will keep you informed of future developments.
