In early May, the bill for the new Electronic Data Exchange in Healthcare Act ("Wegiz" or "bill") was submitted to the House of Representatives. The Wegiz requires healthcare providers to exchange certain data electronically and record it in the same way (textually) in the patient record to be exchanged. The Wegiz also sets detailed technical requirements for the ICT systems healthcare providers use. These new rules should make data exchange in healthcare easier and more efficient. In this article, I discuss what the Wegiz means for practice on the basis of five questions.
Currently, healthcare providers encounter barriers in exchanging patient data. Not only do some healthcare providers still hardly exchange patient data with each other digitally, they also use different ICT systems that do not connect well with each other. As a result, records regularly have to be manually retyped. Moreover, almost all professional groups use their own professional language, which easily leads to misunderstandings about the interpretation of information from a received electronic patient record. Because of the cumbersome process of electronic data exchange in healthcare, a patient's treatment may be delayed, errors are made, or information transfer is too limited or not at all. The bill is intended to change this problematic practice.
In particular, the Wegiz contains obligations for healthcare providers and ICT suppliers. This is because the bill focuses on the mutual exchange of data between healthcare providers. In addition, the bill only deals with data exchange within a number of care domains and not, for example, youth care or research data.
More specifically, the bill applies to "health care providers" within the meaning of the Care Quality, Complaints and Disputes Act ("Wkkgz") who (i) provide care as defined in the Health Insurance Act or the Long-Term Care Act, (ii) perform acts in the field of individual health care as referred to in the Individual Health Care Professions Act or (iii) perform "other care" as defined in the Wkkgz.
Finally, the bill looks at the ICT systems used to exchange patient data.
Through the Wegiz, the electronic data exchange of patient data between healthcare providers should become electronic and standardized. The goal is thus what is known as "unity in language and technology." In a general sense, the bill thus aims to promote the provision of "good care," as referred to in Article 2 of the Wkkgz. Realizing the aforementioned unity is quite a challenge given current practice. That is why the bill has chosen to distinguish between two tracks, first regulating that data must be exchanged electronically and then which data are exchanged as well as the specific requirements the ICT system must meet.
The Wegiz is a framework law that sets some basic guiding rules. The Minister for Medical Care and Sport ("Minister") will have to designate data exchanges to which the requirements of the Wegiz will apply in an Order in Council ("AMvB" or "Decree"). Thus, the Wegiz does not cover data exchanges in a general sense: for each data exchange, it will determine what specific requirements will apply to that data exchange and whether it is a Track 1 or Track 2 designation.
To determine which data exchanges will be designated, the minister has established an agenda. Data exchanges can only be designated by the minister in a decree if they are included in the Multiyear Wegiz agenda (art. 1.3 paragraph 1 jo. 1.4 Wegiz). In addition, a designation requires that a quality standard or legislation or regulations define the data to be exchanged (art. 1.4 paragraph 2 sub a and b Wegiz). Decisions must be approved by the Senate and House of Representatives (art. 6.1 Wegiz).
I briefly explain these components below.
Track 1 (art. 1.4 subsection 3 under a Wegiz) means that a separate decree designates data exchanges that must be exchanged electronically and no longer via a paper fax, CD-ROM or USB stick. The exchange of a PDF is, however, considered a suitable electronic exchange. Furthermore, the designation in track 1 may contain other functional, technical or organizational requirements. These are requirements that do not specifically concern one data exchange but may apply more broadly, such as in the area of authentication and logging.
Next, Track 2 (Article 1.4 subsection 3 sub b Wegiz) sets stricter requirements for electronic data exchange. On the one hand, there will be detailed requirements for the professional language used for the data to be exchanged, and on the other hand, there will be detailed technical requirements for the ICT systems used by healthcare providers. Furthermore, the decree may include rules favorable to "good care." The requirements will all be laid down in a single standard, such as NEN or NEN-EN-ISO. In most cases, these standards have yet to be developed. The intention is to involve the healthcare field in the development.
The Multiyear Wegiz Agenda (art. 1.3 Wegiz) will include which data exchanges are prioritized and will receive a track 1 or track 2 designation. Healthcare parties can propose data exchanges. In order to actually add a data exchange to the Wegiz multi-year agenda, a number of criteria must be met, such as feasibility and the presence of sufficient support in the healthcare field. Four data exchanges are currently being worked out in more detail, with the minister estimating that the first indications will come into effect in 2022 (see here).
A data exchange can only be designated in a decree if it has also been established what data is to be exchanged (Art. 1.4(2) Wegiz). This may involve data that a healthcare provider needs on the basis of a quality standard as referred to in Wkkgz to provide good care. The quality standard describes which data are necessary for good care and is developed/updated jointly with healthcare parties. In addition, it may involve data included in other legislation or regulations and exchanged for the provision of good care or for the purpose thereof. The decision makes reference to these.
In the Explanatory Memorandum to the bill explicitly states that the bill does not create a new basis for the exchange of medical data. As a result, a healthcare provider must first assess whether a legally valid basis exists for the exchange on the basis of the AVG and UAVG and whether medical confidentiality may be breached (arti. 272 Penal Code, art.l 88 BIG Act and art. 7:457 BW (WGBO)).
In order to ensure that designated data exchanges are actually exchanged in accordance with the applicable decree, it first stipulates that the healthcare provider's ICT system must be certified. Although the healthcare provider must ensure that the ICT system actually has a certificate, this is also an important obligation for ICT parties (art. 3.1 et seq. Wegiz).
Supervision is exercised by the Health and Youth Inspectorate, which among other things is given the right to demand information and inspection (art. 4.1 Wegiz). Healthcare providers may also face a written instruction, the application of administrative coercion or an order under penalty (art. 4.2 Wegiz). ICT suppliers who are not certified run the risk of a fine (art. 4.3 Wegiz).
The bill is now before the House of Representatives for consideration. The House of Representatives can make changes to the text. with the result that the text may still change. After that, the bill will be considered by the Senate. If the bill is indeed passed, it will radically change the way healthcare providers exchange data. This will require much from parties involved in the exchange, but the improvement of information exchange can have many positive consequences for patients.
Want to learn more about this topic? Attend the Privacy in Healthcare workshop during the Knowledge Market of Data&Privacyweb on December 7, 2021.
