In order to provide good care, it is crucial that healthcare providers have complete and up-to-date data on patients. This can only be achieved with proper transfer and availability of data between healthcare providers. Both within your own organization and outside it. With the Electronic Data Exchange in Healthcare Act (Wegiz), the healthcare field and the government are jointly taking important steps to achieve this.
On 18 April 2023, the Electronic Data Exchange in Healthcare (Wegiz) Bill was adopted by the Senate. This bill aims to ensure that the relevant data are exchanged electronically and in an unambiguous manner in a timely manner by using ‘unambiguous requirements for language and technology’. It is a framework law, and this means that there will be additional rules stating which data exchanges must take place electronically from when. These rules are called general administrative measures (AMvB). In such an AMvB, for example, it concerns prescriptions that the general practitioner sends digitally to the pharmacy.
The Wegiz will apply to ‘healthcare providers’, which must include both solo care providers (such as general practitioners and pharmacists) and care institutions (hospitals, birth care centers, nursing homes, etc.). The Wegiz is also relevant for software suppliers, now that requirements will be set for the systems that are used for data exchanges. The aim is that the Wegiz will be introduced on 1 July 2023. It differs per data exchange when it will become mandatory.
The proposal for the European Health Data Space (EHDS) was published by the European Commission on 3 May 2022. The EHDS builds on the GDPR and other recent European (draft) regulations regarding the use of data. In addition to the EHDS providing tools for citizens to view their health data and share health data across national borders, the EHDS also provides a framework for using non-identifiable health data for research and innovation. The EHDS is currently still being negotiated. It is still unknown when the text of the regulation will be adopted and when it will enter into force.
In its current form, the EHDS is largely in line with the Wegiz. For this reason, it is expected that many agreements that have been made under the Wegiz will be used as a basis for agreements that will be made under the EHDS.
However, the EHDS does not go as far as the Wegiz. On the basis of the EHDS alone, exchange on paper or by fax remains possible, while Wegiz stipulates that the exchange of data must be done explicitly electronically. The Wegiz thus goes a step further to promote electronic exchange. In addition, the EHDS and the Wegiz use different systems of certification. Under the Wegiz, certification becomes mandatory, while the EHDS assumes self-certification.