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Regulation of Access to Clinical Data in Chile’s New Constitution

By Gabriela Y. Novoa and Alexis M. Kalergis

As Chileans prepare to vote on whether or not to create a new Constitution, an issue worth considering relative to this reform concerns access to clinical data.

The Political Constitution of the Republic of Chile dates back to 1980, and, in the past decades, has undergone several amendments, including key reforms in August 1989, August 2005, and August 2019. As part of this last modification, it was agreed to organize a plebiscite to democratically decide whether or not to elaborate an entirely new constitutional text. If the alternative of generating a new constitution is adopted, it will consist of a constitution written from square one, rather than a modification to the existing text.

As part of the public discussion relative to the potential approval of the need for a new constitution, an open debate has taken place about which issues should or should not be incorporated into this new text.

Among several important themes, the need to regulate the access to clinical data of patients, also called “interoperability,” arises as a major one. Such an issue is linked to the rights to life, to health and privacy protection, individual honor and personal data and property, which are currently established as constitutional guarantees by Article 19 of the current Constitution. Further, the legal framework dealing with this issue is currently mainly found in Law No. 20,584, which regulates the Rights and Duties of individuals in connection with actions associated to their health care, and in Law No. 19,628 (on the protection of the privacy of individuals).

Currently, access to clinical data from patients is only granted to either people directly responsible for the individual’s health care and the patient him/herself (including his/her representative, heirs or agents), with some exceptions linked to judicial investigations, and public health or social security issues.

Such restricted access to clinical information, which is, of course, justified by its sensitive and confidential nature, implies that if a person receives health care at a given place, only that provider will have access to his or her clinical record (unless the patient requests a copy). Therefore, if the patient then sees a different health care provider, the latter will only have access to the clinical record depending on the information provided directly by the patient, and not by the previous provider. The current regulation generates risks for both the patient and the health care provider, since the lack of specific knowledge of clinical history can allow errors in terms of diagnosis or treatment.

The risks described above could be considerably reduced if a system was in place to allow regulated access to clinical information online, available for both public and private health care systems. Thus neither the health care provider nor its location would be relevant for the patient to receive an appropriate and timely new treatment, because the health personnel directly involved in treating the patient will have access to his/her clinical history and to the most relevant clinical data for this particular patient. Access to critical clinical data and medical history will facilitate new successful diagnoses and treatments for Chilean patients.

In addition, patients will have greater freedom to choose health care providers, and to move from one to another, with the assurance that any provider will have access to their clinical history. Likewise, it will force providers to provide better quality, safer, and more efficient service in order to retain patients, and it will allow the government to have access to more information that will enable the adoption of better public policies in the area of health care.

Knowledge of clinical data is a valuable asset for all players in the health system, but it must be handled with the privacy that pertains to information of a sensitive and confidential nature. Therefore, any massive use must be done in a completely anonymous manner.

Thus, the constitutional recognition of the right to have clinical data included in a national health system with free access to health care providers is an improvement that could be implemented as part of changes to the law. However, these changes should include mechanisms that secure confidentiality and privacy of the information. Such legal amendments could constitute great progress in the health care system of our country. Similar achievements have been made in the financial field in Chile, with laws permitting the portability of individual finances and the switching of banking services, such as loans, from one bank to another. These changes have made the system flexible, providing new benefits and opportunities for both users and providers.

 

Gabriela Y. Novoa is a professor of law at Pontificia Universidad Católica de Chile General Counsel for Red de Salud UC CHRISTUS.

Alexis M. Kalergis is a professor in the Department of Molecular Genetics and Microbiology, Faculty of Biological Sciences, Pontificia Universidad Católica de Chile, and professor at the Faculty of Medicine at the same university.

The Petrie-Flom Center Staff

The Petrie-Flom Center Staff

The Petrie-Flom Center staff often posts updates, announcements, and guests posts on behalf of others.

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