The Quality Act or “kwaliteitswet” in Dutch creates a general framework of quality requirements for all healthcare practitioners, regardless of where they practice. In other words, the Act focuses on individual healthcare practitioners, but, in doing so, it affects healthcare institutions too.
The Quality Act: A new law?
The idea of introducing quality legislation in healthcare has been around since April 2019. However, political inaction and the Covid-19 pandemic have caused the actual enactment to be delayed until July 2022, with the option of certain articles of the Act coming into force earlier.
A Royal Decree in that sense was issued in December 2021, which essentially meant the Quality Act was enacted on January 1, 2022, with the exception of provisions on permanency (Art. 21-25), access to health data (Art. 36 – 40), the register of practice (Art. 42 and 43) and the oversight committee (Art. 44 – 63).
What are the applicable terms of the Quality Act (Kwaliteitswet)?
Thus, the following provisions are applicable as of January 1, 2022:
- Diagnostic and therapeutic freedom: healthcare practitioners, within the limits of their power, can freely choose the means they use to provide health care. No regulatory restrictions may be imposed on this;
- Competence and permits: healthcare professionals may only provide health care for which they have the necessary competence and experience. Competence must be demonstrated by means of a portfolio and a permit issued by the Ministry of Finance (FOD Financiën).
- Maintaining patient records: the Act makes it mandatory to do an analysis prior to the implementation of health care if pertinent, which needs to be noted in the patient file;
- Framework: healthcare professionals must ensure that the necessary framework is in place to provide high-quality health care;
- Anxiolysis and anesthesia: if anxiolysis and/or anesthesia is applied, institutions must have a procedure in place to follow in case of problems;
- Prescription: the content of and conditions for issuing medical prescriptions are defined by law;
- Information about Doctor’s Practice: information must be truthful, objective, relevant, and verifiable and should not encourage unnecessary examinations or treatments;
- Patient records: the law in great detail defines the minimum content of patient records. Records must be kept at least 30 years and up to 50 years after the last patient contact. In the future, it will become mandatory to keep electronic records (timing yet to be determined).
What about Patient Files?
- the electronic patient file must enable the minimum content as defined in Art. 33 of the Quality Act;
- This means that healthcare providers can ask for the data in Art. 33 as it’s a legal obligation;
- A shared file preferably follows the structure of art. 33;
- Healthcare practitioners may determine the retention period, but it’s appropriate to determine a general policy that takes the GDPR principles into account;
- From the full entry into force of the Quality Act on July 1, 2022, the Oversight Committee will monitor compliance with the obligations imposed by the Quality Act regarding patient records.
The provisions on permanency, access to health data, register of practice and the oversight committee will not take effect until July 1, 2022.
Access to Health Data
Access to health data is made more difficult by the Quality Act, as it goes beyond the GDPR. In accordance with the GDPR, data sharing can take place as soon as there is a therapeutic relationship. Because of the Quality Law, however, the patient’s consent is also mandatory for any sharing of data. Even though verbal consent suffices, it’s advisable to have written consent as proof.
Furthermore, consent doesn’t have to be given separately for every individual healthcare professional, as patients can choose to give all-in consent. As such, they can allow their data to be processed by the entire practice unit responsible for their care.
Another important element is that patients cannot oppose the creation of a patient file, as it is a legal obligation. They can however oppose their health data being shared with other healthcare providers by excluding individual providers from access or withdrawing their previously given consent.
Healthcare professionals with a therapeutic patient relationship have access to the patient’s personal health data only under the following conditions:
- access may only be given with the aim of providing health care;
- the access is necessary for the continuity and quality of the provided health care;
- the access is limited to the data that is appropriate and sufficient in the context of the provision of health care.
Healthcare professionals who store the patient’s health data need to make sure that the patient has control over the accessibility of their data.
In Full Force
From July 2022 on, when the Quality Law fully comes into force, the Supervisory Commission will monitor healthcare providers’ compliance. If any obligations are violated, an improvement plan can initially be imposed. In case of repeated violations, the healthcare professional’s permit may be suspended or even revoked.
Are you in need of tailored advice as to how to implement these new requirements in your own practice? Don’t hesitate to contact our experts.