healthcare | In Principle

Regulating the secondary use of health data opens up research and analytical opportunities, which can drive scientific progress, new products and devices, digital innovation in the healthcare sector, and improvement of the healthcare system.

All EU citizens will have access to their electronic health records by 2030 thanks to the EU’s central eHealth platform linking national contact points to the MyHealth@EU infrastructure and efficient national digital health authorities.

True cross-border healthcare based on medical documentation accessible throughout the EU via interoperative electronic health data systems. Unleashing the potential of health data for science and  developing new drugs and treatments. These are among the benefits promised by the European Health Data Space.

According to Polish and EU law, performance of certain services requires civil liability insurance. Such an obligation is imposed on entities performing healthcare activities, for which Polish law has specified the minimum amount of coverage. Can such coverage be exhausted by a medical loss?

“Pharmacies for Pharmacists”: this slogan stands for a landmark amendment to the Pharmaceutical Law which has stirred heated debate. Will recent Supreme Administrative Court rulings cut through the controversy surrounding application of the amendment?

What rights do patients—including patients from Ukraine—have in Poland? What should healthcare facilities do when receiving patients from Ukraine? What about filling their prescriptions? And how are the charges for their healthcare services settled?

In 2012, a restrictive ban on advertising by pharmacies was introduced into Polish law. According to Art. 94a of the Pharmaceutical Law, it is only permissible to provide information on the location and working hours of a pharmacy or a pharmacy outlet. Violation of the ban can draw a heavy fine, up to PLN 50,000. In practice, the advertising ban is strictly enforced by the province pharmaceutical inspectors, which results in numerous administrative fines imposed on businesses.

The proposed changes in healthcare in Poland would not only impose new obligations of healthcare providers, but also seek to raise the quality and safety of medical services. Periodic external audits and mandatory reporting of adverse events are to be introduced. This represents an organisational change, but also a cultural one. Every hospital employee would have to be aware of their responsibility towards patients, and all processes would be designed to focus on the patient. The idea of a patient-centred system has been discussed in Poland many times, but not even a uniform definition or principles for such an approach have been adopted to date. It is worth taking a look at how others are doing it.

The law in Poland is quite precise about who can be given information about a family member’s health, and in what situations. But when contacted by a family member by phone, how can the healthcare provider verify the caller’s identity? And can a hospital in principle refuse to provide information by phone?

Convenient access to full medical records is an important goal, but it cannot be pursued contrary to the GDPR and the Constitution. Liability for use of beneficiary’s data for non-medical purposes should also be regulated.

On 22 July 2021, the Ministry of Health published a draft Act on Quality in Healthcare and Patient Safety. The stated purpose of the bill is to implement legal and organisational solutions to improve the quality of healthcare in a comprehensive and coordinated manner. What will change and to what extent?

The European Union is preparing a shared health data space. It is designed to facilitate treatment for Europeans (within the EU) and to consolidate a high standard of medical products and services across all member states. It is also a method for meeting European aspirations for patients’ rights and ensuring more effective treatment and research.