Protection of patients' rights - recommendations of experts

Outline of the problem

The concept of "patient rights" is commonly used today in discussions about health systems, but also in the legal and ethical norms that govern their operation.

The three groups of patient rights include:

1. basic individual rights - to informed consent, privacy, dignity, and access to medical records and information about one's health,
2. Consumer rights - to a choice of provider, a second opinion, safe and timely treatment, and to information on choosing care options,
3. Procedural (procedural) rights - to file a complaint/suit, to compensation and to participate in decision-making.

Poland has had a law on Patients' Rights and Patients' Ombudsman (PPiRPP) for more than thirteen years, in which a catalog of subjective patient rights was first formulated. Epidemiological, technological, institutional and social changes that have occurred since then require work leading to the creation of a new legal and institutional reality affecting the quality of care and patient safety.

Patients' rights as the foundation of health systems - expert recommendations

Academics and practitioners participating in the Polish Health 2.0 project have identified four directions of intervention that seem crucial for a more efficient health system that guarantees the fullest possible respect for patients' rights:

1. Expand the catalog of patient rights and clarify terminological issues

The current PPiRPP Law distinguishes between individual and collective rights of the patient, and the catalog of these rights presented applies to patients receiving health services from public and non-public medical entities and from professional practices. It is advisable to rework the legal definitions of such terms as patient, minor patient, relative, factual guardian, authorized person, and to include the concept of "substitute patient representation."

It is worth considering special regulations for groups that require additional legal guarantees for the protection of subjective rights: children, including children with disabilities, women during pregnancy, childbirth and postpartum, or the elderly.

The concept of a health care provider needs to be expanded beyond medical entities and the professional practices of a doctor, nurse, midwife or physiotherapist.

It is also important to decide whether the provisions of the law also apply to the provision of health care services in social welfare facilities or pharmaceutical care provided in pharmacies, but also to services provided by a psychologist or psychotherapist in therapeutic offices.

1. The introduction of an out-of-court model of medical damage compensation based on no fault ( eng. no fault)

The practice of healthcare entities' implementation of their obligation to compensate patients for medical incidents regulated by the PPiRPP Act is currently very unfavorable to injured persons. Hospitals refuse or underpay the amounts intended to compensate for the damage suffered despite the settlement favorable to the injured party.

Given the rapid development of medicine, medical sciences and technical and engineering sciences in these scientific disciplines and the development of telemedicine, it is necessary to create and implement a coherent and effective out-of-court no fault system to compensate for the harm suffered by patients.

The new model should be based on the principle of not adjudicating the guilt of medical personnel, in exchange for the implementation of a rapid, efficient system for monitoring the reporting of adverse events by medical personnel and the ongoing verification of these events, thereby removing identified adverse situations that could threaten patient safety. The legal literature postulates the introduction in Poland of mechanisms to compensate for damages caused in the provision of health services under the insurance-guarantee model. These damages would be subject to compensation from a specially created compensation fund financed by public funds (taxes or a targeted contribution).

Following the example of many European countries that have experience with the implementation and operation of the out-of-court model of redress, the tasks related to the operation of the out-of-court no fault system compensating for damages suffered by patients should be carried out by specialized public or insurance agencies, which would be responsible for carrying out adjudicatory, analytical, statistical and preventive tasks.

1. Change in the mode of appointment to the post of Patient Ombudsman (PPC)

Currently, the MPC is selected through a competition conducted by the Minister of Health and appointed by the Prime Minister. The Prime Minister of the RM is both the superior of the Health Minister and the Patient Ombudsman - as a "reviewer" of the policies implemented by the Health Ministry. The recruitment procedure for the position of MPC, carried out by a team appointed by the Minister of Health, from the outset strains the authority of the MPC, whose mission, by definition, is to be an objective, uncompromising and firm guardian of patient rights.

In order for this mission to be effectively carried out, it is necessary to change the rules for the selection of the person for the office of Patient Ombudsman to his election by the parliament, with the consent of the senate, upon the proposal of the speaker of the parliament, the speaker of the senate, a group of at least 35 deputies or at least 15 senators.

It is also necessary to make the MPC office independent of the executive branch.

1. Processing and security of personal data sharing in the medical sector

Currently, patients' medical data remain locked in the digital databases of the Internet Patient Account. The overriding goal of managing them is to ensure data privacy. Instead, it is very difficult to use this data for medical research for the benefit of patients and the development of medicine.

In order to achieve these two goals, the following actions are necessary:

1. To review existing Polish legal acts and bring them in line with the standards of the Medical Data Management Regulation.
2. Determining the rules for the designation of competent entities authorizing the reuse of certain categories of protected data to support the activities of public sector (including health) entities.
3. Determining the rules for designating the entity responsible for assisting public sector entities granting or denying access to categories of health data for reuse purposes.
4. Determine the rules for the establishment or designation of an existing entity as an information point.
5. Defining rules for the establishment and operation of focal points to support researchers and innovative companies in identifying relevant data, including health data.
6. Determining the conditions for the provision of health data brokerage services to be met by entities on the subject of ensuring a safe environment in which companies and individuals can share health data.
7. Determining the rules for maintaining a register and the form of a register of intermediary service providers.
8. Defining rules for monitoring and supervising intermediary service providers.
9. Determining the principle of designating at least one competent authority to perform tasks related to the notification procedure for data brokerage services.
10. Determining the rules for registering organizations with an "altruistic" approach to data, as well as the conditions that such an organization should meet and under which it should operate.
11. Determine the rules for the designation and operation of the body responsible for maintaining a public national register of recognized organizations with an "altruistic" approach to data.
12. Establish penalty provisions applicable to violations.

In the context of the issue of processing personal medical data, the European Strategy for Data will be of key importance for the national health sector. The solutions proposed in European regulations are intended to serve the needs of advanced processing of large data sets, including medicaldata (Big data).

The 4 directional changes described above should be to work on concretizing patient rights and preparing rules for their implementation. In the process of formulating and clarifying them, it is worth taking advantage of the experience of other countries, as well as being inspired by the international recommendations of organizations such as the WHO(World Health Organization) and the document prepared by this organization, "Global Action Plan 2021-2030 - the way to eliminate preventable harm in health care."

The above recommendations are discussed in detail in the policy brief titled. "Strategic Recommendations for 2023-2027: SELECTED PROBLEMS FOR PATIENT RIGHTS - Polish Health 2.0".