Chapter 19 Some Comments Regarding the Digitalisation of the Health Care System in Poland during the COVID-19 State of Epidemic

Selected Legal Aspects

In: Complexity and Simplicity
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Katarzyna M. Zoń
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Abstract

In modern times, the development of science and technological progress have together created new prospects for the provision of health services. These opportunities are of key importance to the functioning of healthcare systems themselves. This article is devoted to analysing the legal dimension of the digitalisation of the healthcare system in Poland, along with the consequences of such a process. The validity and usefulness of the subject matter are justified by the current pandemic situation. In this context, it should be emphasised that the above-mentioned process has recently accelerated. The implementation of this solution is aimed at improving the effectiveness of healthcare service provision. Digitalisation therefore needs to be discussed with reference to its role as an important component of the healthcare system in Poland.

1 Introduction

Modern technological progress creates new opportunities and perspectives for the implementation of innovations in many areas. The introduced solutions also have a key impact on the functioning of the health care system. A clear indication of the above changes is the digitalisation process, the implementation of which has accelerated significantly in this field recently.

This observable tendency justifies the analysis of selected legal aspects of digitalisation of the public health care system in Poland by taking into consideration how this process occurred during the COVID-19 epidemic.1 The validity and usefulness of the subject matter are confirmed by the practical significance and topicality of the issues raised. During this unique epidemic situation, the key challenge was to properly organise the form of providing health care services. On the one hand, the availability and continuity of health services had to be ensured, and – on the other – the safety of health professionals and patients had to be guaranteed. The aim of this paper is to draw attention to Polish legal regulations constituting the digitalisation process in the provision of health services, which were introduced during the COVID-19 pandemic. Although modern solutions were identified within the time frame of this specific period, in reality, they are part of the earlier initiated digitalisation process of the health care system in Poland. A comprehensive approach to the considerations also requires indicating the tools introduced earlier and providing an overview of the regulatory environment in existence at the time. The conclusions systematise observations and remarks concerning the review of select legal regulations from the perspective of the current moment.

2 Outline of the State of the Digitalisation of the Health Care System in Poland before the COVID-19 State of the Epidemic

As already mentioned, even before the COVID-19 pandemic, there were solutions in place in Poland that constituted part of the digitalisation process of the public health care system. Taking into account the broader regulatory framework, it is worth mentioning that since 12th December 2015, the Polish legislator has widely allowed the possibility of providing health care services in the telemedicine model, i.e., via ICT systems or communication systems.2 Necessary legal provisions have been provided for in the Medical Care Act,3 among others, and in acts relating to the exercising of individual medical professions.4 However, issues related to its financing still remain an important practical barrier to the widespread provision of telemedicine in the public healthcare system. Despite the introduction of the general possibility of providing such health services, only some of them were covered by public financing. This applies, for example, to cardiac teleconsultation, geriatric teleconsultation, hybrid cardiac telerehabilitation and medical consultation in primary health care carried out remotely, i.e., via ICT systems or communication systems.5 The latter has gained particular importance during the COVID-19 pandemic era, which will be presented below as part of this paper. The aforementioned general provisions were linked to specific legislative changes in the area of health care digitalisation aimed at improving the health care services provision process. The key in this respect was the successive implementation of subsequent process phases, i.e., medical sick e-notes6 and e-prescriptions.7 An Internet Patient Account (Pol.: Internetowe Konto Pacjenta, IKP) was also launched,8 with the scope of its functionality extended over time. This tool allows patients to access their medical records, information about issued sick leaves, completed referrals, prescriptions, as well as about their current entitlement to healthcare services or the amount of health insurance premiums paid by the patient. Moreover, via IKP, the patient can authorise another person to access his or her medical data or information regarding health, as well as give consent to the provision of health services.

3 Select Examples of Digitalisation of the Polish Health Care System during the COVID-19 State of the Epidemic

3.1 Electronic Referrals (E-Referrals)

With the aforementioned in mind, it is worth expanding on the outlined system of legal regulations with norms constituting aspects of the health care system digitalisation process in Poland, and which came into force during the COVID-19 pandemic. It should be indicated that these are not of a uniform nature. The first group includes solutions introduced at a predetermined time, which were introduced irrespective of the specific epidemic situation. Conversely, the second category comprises instruments implemented in connection with the provision of health care services in these specific circumstances.

With regards to e-referrals,9 which is an aspect of the health care system digitalisation that falls within the first of the above groups, it should be clarified that the obligation, existing since 8th January 2021, to issue referrals in electronic form applies only to specific documents, recorded in the Medical Information System (Pol.: System Informacji Medycznej SIM). This is because not all referrals issued to enable the patient to access specific health services are of such a nature. The list established by way of a regulation of the Minister of Health10 lists specific types of medical services, taking into account the manner of their financing and the rules of their implementation. The electronic form referral includes: outpatient specialist services financed from public funds, excluding specialist advice – speech therapy, as well as publicly funded fetal echocardiography examinations, publicly funded gastrointestinal endoscopic examinations, publicly and non-publicly funded nuclear medicine examinations, publicly funded magnetic resonance imaging examinations, publicly and non-publicly funded computed tomography examinations, hospital treatment, therapeutic rehabilitation, health resort treatment and rehabilitation. However, referrals for other services, such as drug programmes, can still be issued in paper form. Similarly, this encompasses diagnostic tests or certain procedures that are performed for a patient as part of specialist advice, hospitalisation, as well as in the absence of access to the ICT system (for example, system failure) and in the case of issuing a referral for a person of unknown identity.

3.2 Electronic Medical Records

Another indication of digitalisation, not directly resulting from the unique epidemiological situation, can be seen in the field of electronic medical records. However, the aforementioned solution is not a brand-new instrument. As early as 1st January 2019, healthcare institutions were obliged to keep certain documents in an electronic form such as disease, health problem or injury diagnosis information, test results, refusal of hospital admission justifications, health services provided and possible medical orders – in the case of a patient being refused admission to hospital, information for the doctor referring the recipient to a specialist clinic or hospital treatment concerning the diagnosis, treatment method, prognosis, prescribed drugs, foodstuffs for special nutritional purposes and medical devices, including the usage period and dosage method, as well as scheduled control visits and information sheets from hospital treatment.11

Over time, the above obligation incorporated additional documents, e.g., laboratory test results with descriptions and diagnostic test descriptions other than the above. Electronic medical records12 are documents created in an electronic form with a qualified electronic signature, a trusted e-signature, a personal signature or by way of confirming the origin and integrity of data available in the ICT system made available free of charge by the Social Insurance Institution, i.e., prescriptions, referrals, orders for supplies and repairs and vaccination cards, as well as documents which it was obligatory to keep in the form of electronic records at an earlier date.13 In addition, since 1st July 2021, the healthcare provider is obliged to ensure that it is possible to exchange the data contained in the electronic medical records via the SIM system.14 The listed catalogue of documents is to be expanded to include all documentation maintained by the healthcare provider. The above solution is intended to improve the system of medical record circulation between healthcare providers, guaranteeing proper cooperation and giving assurance of comprehensive care for patients. Automatic access to electronic medical records is available to designated entities: the medical employee who created the electronic medical records containing the patient’s personal data or individual medical data, the medical employee practising at the service provider where electronic medical records containing a patient’s personal data or individual medical data has been created in connection with his/her practising at this service provider if it is necessary to carry out diagnostics or ensure continuity of treatment, as well as the doctor, nurse or midwife providing healthcare services to the service recipient under the healthcare services provision agreement in the field of primary healthcare and all medical personnel in a situation that is life-threatening for the patient.15 In other cases, access to medical records requires the consent of the patient or his or her legal representative, while indicating the scope of time and subject matter of data access.

3.3 Teleconsultations

Given the need to reduce direct contact between patients and medical professionals in the COVID-19 pandemic era, teleconsultation provided in primary care has become essential. Crucially, these services have been included as part of publicly funded benefits since November 2019. A teleconsultation is a health service provided remotely using ICT or communication systems, and carried out as part of primary health care (PHC) by a doctor, nurse or midwife who provides services at a PHC provider. This can especially take the form of a conversation over the phone, a video conference or exchange of electronic correspondence (emails). The dynamic increase in the amounts of teleconsultations practiced observed during the COVID-19 epidemic directly influenced the necessity to develop organisational standards regarding their provision. Within the scope of the implemented principles, which changed three times during the time the state of the epidemic was in force,16 the duties of the primary care provider and the teleconsultation provider have been listed. These include, above all, obligations towards the patient regarding the provision of information. One such obligation that should be emphasised is providing the patient with information about the terms and conditions of teleconsultation provision, including the patient’s right to express their wish to have personal contact with relevant medical staff, specifying, e.g., the services to be provided through direct patient contact only, how the date and time of the teleconsultation is to be determined or how to establish contact with the patient. It is also worth mentioning their report duties towards the National Health Fund, which in turn allow the latter to monitor the health services provided in this form, but also it should be indicated that there is a necessity to record the provision of teleconsultation services in the medical documentation and to conduct it maintaining confidentiality. Wider use of teleconsultation in the pandemic was also fostered by complementary digitalisation tools, such as the aforementioned e-prescriptions, e-referrals or e-notes.

3.4 Public Financing of Health Services Provided under the Telemedicine Model

The COVID-19 pandemic also increased the scope of publicly funded health services delivered using ICT or communications systems. Some of them were reimbursements covered regardless of the epidemic situation, while others only during the state of epidemiological threat or the state of epidemic emergency. The first group includes such services as the provision of advice and visits in the field of palliative and hospice care in a home setting with the use of ICT systems or other communication systems, provided that such a procedure does not pose a risk of causing the deterioration of the patient’s health condition,17 guaranteed benefits within the scope of nursing and home care services within the framework of long-term care, provided under home conditions by a long-term home care team or long-term home care nursing service,18 as well as outpatient guaranteed benefits within the scope of psychiatric care and community (home) mental treatment and addiction treatment, which can be provided with the use of ICT systems on condition that the availability of personnel required to provide them at the place of benefit provision is ensured.19 Other services have only been approved temporarily (during the state of epidemiological threat or the state of epidemic emergency). They include the provision of guaranteed benefits (within the scope of haemodialysis and haemodialysis with 24-hour stand-by services) by an authorised physician, using the ICT systems or communication systems, if this manner of provision of benefits does not pose a threat to a patient’s life or could lead to a deterioration of his/her health condition, and a nurse with appropriate qualifications is present at the patient’s side.20 This also covers the scope of guaranteed benefits in the area of therapeutic rehabilitation, provided under conditions of outpatient, home or day wards, a possibility of providing medical advice, with counselling or therapeutic visits using ICT systems or communication systems having been admitted, if this method of providing healthcare does not pose a threat to the deterioration of the health condition of the benefit recipient.21 Due to the cessation of the special circumstances (state of an epidemic or an epidemic threat), there are currently no legal bases for the refunding of the above services provided with the use of information and communication (ICT) systems.

4 Patient Identification and Confirmation of Entitlement to Benefits

During the COVID-19 pandemic, there were several additional solutions provided for facilitating the identification of a patient or confirming eligibility for a given service,22 the introduction of which was directly related to the existing epidemiological situation. On this basis, entities providing healthcare services via ICT systems or communications systems were allowed to confirm the identity of the recipient based on data provided by the recipient via those systems, including by telephone. In addition, certain formal obligations concerning the provision of health care services did not apply to appeals (among others, the obligation to submit to the provider within 14 days the original copy of the referral as part of health care services financed from public funds). It was also made possible to issue instructions for the provision of medical devices and repair orders via ICT systems or communication systems. The functionality of the above-mentioned tools, which in some situations may also have proven useful after the end of the extraordinary epidemiological situation justifying their implementation, has not been maintained.23

5 Conclusions

With these considerations in mind, it should be emphasized that digitalisation continues to constitute a significant challenge for the public health care system in Poland. The accomplishment of subsequent stages of this process is aimed at streamlining and improving the efficiency of healthcare services, enabling the implementation of personalized patient care. Moreover, progressing digitalisation fosters the further development of telemedicine, for which it remains extremely important to solve the issue of the financing of this type of health service provision.

The announcement of the COVID-19 state of epidemic made it necessary to reach for other ways of providing health care services, serving as an impetus for a more in-depth analysis of the functioning of the health care system in Poland. For epidemiological reasons, ensuring access to health care had to be accompanied by simultaneous efforts to minimise the risk of infection among medical personnel and patients. The experience gained during the epidemic, related to the need to reduce direct contacts has highlighted the pivotal role played by digitalisation in the overall functionality of the health care system. There is no doubt that it is an inevitable process for the creation of a modern model of the health care system serving the needs of both patients and medical professionals. In this context, it is worth remembering that technology should strengthen the traditional health service model and not seek to replace it. The COVID-19 state of epidemic undoubtedly contributed to wider use of previously functioning tools, whose potential had not been recognised before. A manifestation of this was, for example, the dynamic increase in the use of teleconsultation in the diagnostic and therapeutic process. It remains an open matter to what extent the solutions developed in the area of health care will function after the extraordinary epidemic circumstances have ceased to exist. However, an assessment of this aspect requires further consideration in the future, after some time has passed.

Notes

1

The state of epidemic in Poland lasted from 20 March 2020 to 15 May 2022.

2

Act of 9th October 2015 amending the information system in health care act and some other acts (Journal of Laws, item 1991).

3

Cf. Art. 3 (1) of the Medical Care Act of 15th April 2011 (consolidated text Journal of Laws 2023, item 911 as amended).

4

Cf. Article 2(4) of the Act of 5th December 1996 on the doctor and dentist professions (consolidated text Journal of Laws 2023, item 1516 as amended), Article 11(1) of the Act of 15th July 2011 on the nurse and midwife professions (consolidated text Journal of Laws 2022, item 2702).

5

Regulation of the Minister of Health of 31st October 2019 amending the regulation on guaranteed services in the field of primary health care (Journal of Laws, item 2120).

6

Cf. Article 55 of the Act of 25th June 1999 on cash benefits from social insurance in the event of sickness and maternity (consolidated text Journal of Laws 2022, item 1732). Sick leave in the form of an electronic document (e-note) has been issued since 1st January 2016 (parallel with a paper form). However, as of 1st December 2018, this e-note is now the exclusive form.

7

Cf. Article 95b of the Act of 6th September 2001. Pharmaceutical Law (consolidated text Journal of Laws 2022 item 2301 as amended). Prescriptions in electronic form (e-prescriptions) have been issued since 18th April 2018. This form has become obligatory since 1st January 2020 with some exceptions, e.g., the possibility to issue paper prescriptions e.g., for persons of unknown identity or pro auctore prescriptions (for the prescribing doctor himself) and pro familiae prescriptions (for persons close to the prescribing doctor – spouses, ascendants, descendants or siblings).

8

The Internet Patient Account has been functioning in the Polish legal framework since 23rd August 2018 (Act of 20th July 2018 on amending the information system in health care act and some other acts, Journal of Laws 2018, item 1515).

9

Cf. Article 59aa of the Act of 27th August 2004 on health care services financed from public funds (consolidated text Journal of Laws 2022, item 2561 as amended). Referrals in electronic form (e-referrals) have been issued since 1st April 2019. This form has become the exclusive form since 1st January 2021 with regards to documents recorded in the Medical Information System.

10

Cf. § 2 of the Regulation of the Minister of Health of 15th April 2019 on referrals issued in electronic form in the Medical Information System (consolidated text Journal of Laws 2022, item 1417 as amended), which came into force on 18th April 2019.

11

Cf. Article 56(1) of the Act of 28th April 2011 on the information system in health care (consolidated text Journal of Laws 2022, item 1555 as amended).

12

Cf. Article 2(6) of the Act of 28th April 2011 on the information system in health care (consolidated text Journal of Laws 2022, item 1555 as amended).

13

Cf. § 1 Regulation of the Minister of Health of 8th May 2018 on types of electronic medical records (consolidated text Journal of Laws 2023, item 1851), which entered into force on 2nd June 2018.

14

Cf. Article 56(4) of the Act of 28th April 2011 on the information system in health care (consolidated text Journal of Laws 2022, item 1555 as amended).

15

Cf. Article 35 (1) and (1a) of the Act of 28th April 2011 on the information system in health care (consolidated text Journal of Laws 2022, item 1555 as amended).

16

Regulation of The Minister of Health of 12th August 2020 on the organisational standard of teleconsultation in primary health care (consolidated text Journal of Laws 2022, item 1194).

17

Regulation of the Minister of Health of 16th March 2020 amending regulation on the guaranteed services in the field of palliative and hospice care (Journal of Laws, item 457), which entered into force on 17th March 2020.

18

Regulation of the Minister of Health of 16th March 2020 amending the regulation on guaranteed benefits in the field of nursing and care services in long-term care (Journal of Laws 2020, item 460), which entered into force on 17th March 2020.

19

Regulation of the Minister of Health of 16th March 2020 amending the regulation on guaranteed benefits in the field of psychiatric care and addiction treatment (Journal of Laws, item 456), which entered into force on 17th March 2020.

20

Regulation of the Minister of Health of 6th April 2020 amending the regulation on guaranteed benefits in the field of outpatient specialist care (Journal of Laws, item 612), which entered into force on 8th April 2020.

21

Regulation of the Minister of Health of 10th April 2020 amending the regulation on guaranteed services in the field of medical rehabilitation (Journal of Laws, item 660), which entered into force on 11th April 2020.

22

The legal basis for their functioning was the Regulation of the Council of Ministers on establishing certain restrictions, orders and prohibitions in connection with the occurrence of an epidemic.

23

Regulation of the Council of Ministers of 27 June 2023 repealing the Regulation on the establishment of certain restrictions, orders and prohibitions in connection with the occurrence of an epidemic emergency (Journal of Laws, item 1233), which entered into force on 1 July 2023.

References

  • Act of 5th December 1996 on the doctor and dentist professions (consolidated text Journal of Laws 2023, item 1516 as amended).

  • Act of 25th June 1999 on cash benefits from social insurance in the event of sickness and maternity (consolidated text Journal of Laws 2022, item 1732 as amended).

  • Act of 6th September 2001 Pharmaceutical Law (consolidated text Journal of Laws 2022 item 2301 as amended).

  • Act of 27th August 2004 on health care services financed from public funds (consolidated text Journal of Laws 2022, item 2561 as amended).

  • Medical Care Act of 15th April 2011 (consolidated text Journal of Laws 2023, item 911 as amended).

  • Act of 28th April 2011 on the information system in health care (consolidated text Journal of Laws 2022, item 1555 as amended).

  • Act of 15th July 2011 on the nurse and midwife professions (consolidated text Journal of Laws 2022, item 2702 as amended).

  • Act of 9th October 2015 amending the information system in health care act and some other acts (Journal of Laws, item 1991).

  • Act of 20th July 2018 on amending the information system in health care act and some other acts (Journal of Laws, 2018 item 1515).

  • Regulation of the Council of Ministers of 27th June 2023 repealing the Regulation on the establishment of certain restrictions, orders and prohibitions in connection with the occurrence of an epidemic emergency (Journal of Laws, item 1233).

  • Regulation of the Minister of Health of 8th May 2018 on types of electronic medical records (consolidated text Journal of Laws 2023, item 185).

  • Regulation of the Minister of Health of 15th April 2019 on referrals issued in electronic form in the Medical Information System (consolidated text Journal of Laws 2022, item 1417 as amended).

  • Regulation of the Minister of Health of 31st October 2019 amending the guaranteed services in the field of primary health care (Journal of Laws, item 2120).

  • Regulation of the Minister of Health of 16th March 2020 amending the guaranteed benefits in the field of psychiatric care and addiction treatment decree (Journal of Laws, item 456).

  • Regulation of the Minister of Health of 16th March 2020 amending the guaranteed services in the field of palliative and hospice care decree (Journal of Laws, item 457).

  • Regulation of the Minister of Health of 16th March 2020 amending the guaranteed benefits in the field of nursing and care services in long-term care decree (Journal of Laws, item 460).

  • Regulation of the Minister of Health of 6th April 2020 amending the guaranteed benefits in the field of outpatient specialist care decree (Journal of Laws, item 612).

  • Regulation of the Minister of Health of 10th April 2020 amending the guaranteed services in the field of medical rehabilitation decree (Journal of Laws, item 660).

  • Regulation of the Minister of Health of 12th August 2020 on the organisational standard of teleconsultation in primary health care (consolidated text Journal of Laws 2022, item 1194).

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  • Act of 5th December 1996 on the doctor and dentist professions (consolidated text Journal of Laws 2023, item 1516 as amended).

  • Act of 25th June 1999 on cash benefits from social insurance in the event of sickness and maternity (consolidated text Journal of Laws 2022, item 1732 as amended).

  • Act of 6th September 2001 Pharmaceutical Law (consolidated text Journal of Laws 2022 item 2301 as amended).

  • Act of 27th August 2004 on health care services financed from public funds (consolidated text Journal of Laws 2022, item 2561 as amended).

  • Medical Care Act of 15th April 2011 (consolidated text Journal of Laws 2023, item 911 as amended).

  • Act of 28th April 2011 on the information system in health care (consolidated text Journal of Laws 2022, item 1555 as amended).

  • Act of 15th July 2011 on the nurse and midwife professions (consolidated text Journal of Laws 2022, item 2702 as amended).

  • Act of 9th October 2015 amending the information system in health care act and some other acts (Journal of Laws, item 1991).

  • Act of 20th July 2018 on amending the information system in health care act and some other acts (Journal of Laws, 2018 item 1515).

  • Regulation of the Council of Ministers of 27th June 2023 repealing the Regulation on the establishment of certain restrictions, orders and prohibitions in connection with the occurrence of an epidemic emergency (Journal of Laws, item 1233).

  • Regulation of the Minister of Health of 8th May 2018 on types of electronic medical records (consolidated text Journal of Laws 2023, item 185).

  • Regulation of the Minister of Health of 15th April 2019 on referrals issued in electronic form in the Medical Information System (consolidated text Journal of Laws 2022, item 1417 as amended).

  • Regulation of the Minister of Health of 31st October 2019 amending the guaranteed services in the field of primary health care (Journal of Laws, item 2120).

  • Regulation of the Minister of Health of 16th March 2020 amending the guaranteed benefits in the field of psychiatric care and addiction treatment decree (Journal of Laws, item 456).

  • Regulation of the Minister of Health of 16th March 2020 amending the guaranteed services in the field of palliative and hospice care decree (Journal of Laws, item 457).

  • Regulation of the Minister of Health of 16th March 2020 amending the guaranteed benefits in the field of nursing and care services in long-term care decree (Journal of Laws, item 460).

  • Regulation of the Minister of Health of 6th April 2020 amending the guaranteed benefits in the field of outpatient specialist care decree (Journal of Laws, item 612).

  • Regulation of the Minister of Health of 10th April 2020 amending the guaranteed services in the field of medical rehabilitation decree (Journal of Laws, item 660).

  • Regulation of the Minister of Health of 12th August 2020 on the organisational standard of teleconsultation in primary health care (consolidated text Journal of Laws 2022, item 1194).

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