At the end of January, the ICT & Health World Conference took place at the MECC in Maastricht. Together with my colleague Tom Beumers, I attended the conference. It was a day full of inspiring innovations and transformations in healthcare. We heard, for example, about healthcare providers replacing physical consultations with online alternatives, and how smart technologies, such as home monitoring, can even make some appointments unnecessary. Much attention was also paid to the role of new healthcare legislation, such as the European Health Data Space Act (EHDS), and the importance of proper implementation. In this blog, we take a closer look at a few highlights of the day.
Digital transformation
The day started with a keynote session in which, among others, the Chief Information Officer (CIO) of the Ministry of Health, Welfare and Sport (VWS), Bianca Rouwenhorst, spoke about the future resilience of healthcare. As you are likely aware, the healthcare sector faces major challenges, including rising costs, an ageing population and shortages of healthcare staff. According to the CIO, digital transformation is the key to addressing these challenges.
For this transformation to succeed, she argued, we must focus on three concepts: trust, collaboration and action. Digital transformation depends not only on technology, but also on the trust of patients and healthcare professionals to exchange data securely. Collaboration between the various stakeholders is actively encouraged. We see that many of our clients are already working hard on this, with numerous infrastructures being developed.
There was also a clear call to the field to get started and not wait for ‘perfect clarity’. This practical vision aligns well with what we stand for. At the same time, we would like to emphasise the importance of already factoring in the requirements of future legislation, such as the EHDS, when designing new initiatives. Only in this way can a future-proof solution be created.
EHDS
It would go too far to discuss all sessions in detail. However, I would like to highlight a session organised by VWS entitled ‘the EHDS at a glance’. This was the session I personally looked forward to most. In this session, VWS provided further explanation of the EHDS and outlined how the ministry interprets it. Several interesting and relevant points emerged.
The discussion focused mainly on the scope of primary use. This refers to the use of personal electronic health data for the provision of care. The EHDS establishes a legal basis for the exchange of such data. But in which situations does this legal basis apply, now and in the future? VWS assesses this based on three elements:
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type of care;
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type of healthcare provider;
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type of data.
Care
For the concept of care and when it qualifies as such under the EHDS, VWS follows the definition set out in the Patients’ Rights Directive. More specifically, according to VWS this concerns publicly funded and accessible care. As a rule of thumb, this includes care reimbursed under the Health Insurance Act (Zvw) and or the Long-term Care Act (Wlz). Forensic care and military healthcare are explicitly excluded.
VWS emphasised that this means many forms of youth care do not qualify as healthcare within the meaning of the EHDS but are social and educational in nature. This is different in the case of youth mental healthcare where a BIG-registered professional is involved. As a result, youth care appears to fall largely outside the scope of the EHDS for primary use. Youth care providers may, however, fall under the regime for secondary use, depending on which data they hold digitally.
Healthcare provider
For the concept of ‘healthcare provider’, VWS also follows the Patients’ Rights Directive. This is defined as ‘a natural or legal person, or another entity, that lawfully (that is, in a regulated manner) provides healthcare within the territory’. VWS applies the rule of thumb that this concerns a healthcare provider within the meaning of the Healthcare Quality, Complaints and Disputes Act (Wkkgz) or a BIG-registered professional. The Wkkgz provides that a healthcare provider includes both institutions and self-employed healthcare professionals.
Prioritised data
Finally, the rules on primary use apply only to the prioritised data. While this may sound like a limitation, these data categories are defined very broadly. The more relevant question may be what does not fall within scope. The prioritised data include:
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patient summaries;
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electronic prescriptions;
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electronic dispensations;
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medical images and related reports;
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laboratory results.
If, as a healthcare provider, you meet the requirements set out above, VWS takes the view that you will, in the future, must comply with the rules applicable to primary use.
Time to act!
In short, it was an interesting day with a clear message: action is required. The upcoming entry into force of the EHDS played a prominent role throughout the day. This is hardly surprising, as the EHDS is expected to be published in the Official Journal of the European Union in the coming days. Twenty days after publication, the EHDS will enter into force. The obligations will not apply immediately, however.
The EHDS will be implemented in phases over the coming years. The first obligation will apply in two years’ time and the last in six years. This may seem far away, but it is important for healthcare providers to start preparing now. Significant changes are coming, and it is essential to involve the organisation in this process. For example, check whether your current systems are set up in a way that allows compliance with the EHDS. If not, start the conversation with your supplier.
If you have any questions about the EHDS, please do not hesitate to contact us. We are happy to think along with you. Or download our EHDS cheatsheet.
