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In June, the Lower House considered a legislative amendment requiring hospitals to submit patient data for quality registrations. Medical specialists welcome this development as it will make registrations more complete and reduce the administrative burden. Martin Buijsen, Professor of Health Law at Erasmus School of Law, shared his insights on the matter in an article in Medical Contact.
The new law, the Care Quality Registration Act, aims to put an end to the proliferation of quality registrations and requires hospitals and independent treatment centres (zbc's) to submit patient data pseudonymised. Patients do not have to give their consent to this. For now, the legislation only applies to medical-specialist care, excluding mental health care.
The breakthrough of medical secrecy?
According to Buijsen, the breach of medical secrecy is well defensible in this case. "The healthcare provider's duty of secrecy can be subordinated to larger interests, such as promoting the quality of our healthcare. This is also not unique: there are more laws that allow professional secrecy to be breached." Buijsen argues that patients do need to be informed about these new legal provisions, for instance through government and healthcare provider websites.
One of the main benefits of the change in the law is that the mandatory submission of patient data reduces the administrative burden. Currently, doctors often have to enter additional data into electronic health records (epd's) that are not properly aligned with quality registrations. The new legislation allows pressure on epd providers to better align their systems with registrations.
Buijsen acknowledges that a lot of time is spent on administrative tasks in healthcare. Although he questions the usefulness of some administrative operations, he believes everyone agrees on the importance of quality registrations. These registrations originated from the healthcare sector itself to improve the quality of care. In turn, the government has an obligation to ensure that this processing of personal data complies with the General Data Protection Regulation.
Permission
Buijsen explains that the ethical principle of respect for autonomy sometimes means that implicit patient consent is sufficient for processing data, especially when it comes to using it to improve quality of care. "It is a misconception to think that respect for autonomy in healthcare and medicine always boils down to explicit consent. The Medical Treatment Agreement Act has long had provisions overseeing the anonymous use of patient data and bodily material for the purpose of medical-scientific, medico-statistical and scientific research in the field of public health, which assume no objection, so of implicit consent", Buijsen adds. The legislative proposal further regulates that the data must be encrypted at source, e.g. at the hospital or zbc, to prevent misuse.
The mental health sector has been exempted from compulsory quality registrations for now because of the wide variation in treatments and the lack of agreement on outcome measures. However, Buijsen does not rule out quality registrations for the mental health sector in the future. "Too many institutions and healthcare providers treat the same conditions differently, and there is also a lack of agreement on outcome measures. This is somewhat different in somatic care at the moment. Those forms of care are more tightly protocolled and there is more agreement on outcome measures. But it is certainly not out of the question that there will be quality registrations of mental health care in the future."
Transparency, privacy and collaboration in the healthcare sector
Buijsen further stresses that healthcare providers are the first to inform patients about the use of their data for quality registrations. He advocates intensive cooperation between healthcare providers and patients to raise awareness. The new law should not only improve the quality of care but also clarify the legal frameworks around privacy. Mandatory data delivery must comply with strict privacy rules to ensure that patient data is used safely and responsibly.
This change in the law could be an important step in increasing transparency and quality of care in the Netherlands. Buijsen and other experts hope that these new regulations will lead to better healthcare outcomes and more streamlined administration within the healthcare sector.
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Read Martin Buijsen his entire contribution to the Medical Contact article here (provided in Dutch only).