Parties to the Medical Services Contract and Their Core Obligations (Primarily under Georgian and German Law)

Abstract

Creating a legal framework to regulate contractual relations between patients and healthcare providers, or improving the existing one, is the main task of any legal system. In this process, it is necessary to take into account the specifics of legal relations, analyze the challenges in practice, and based on them, determine the rights and obligations of the parties on a fair basis.

This article analyzes the legal and factual situation of the parties to a medical service contract, the challenges they face, and ways to overcome them. Special attention is paid to the issue of providing medical services to minors and patients who cannot make informed decisions, and the scope of participation of their parents, legal representatives, and relatives in this process.

In addition, the article discusses the main obligations of the medical service provider. Of course, the specific rights and obligations of the parties are determined in each case based on their needs and an individual contract. However, in this case, the legal and ethical obligations common to any medical service contract are analyzed, namely the obligation of the medical service provider to inform the patient, take care of him, protect confidentiality, and maintain medical records.

The article is mainly prepared according to Georgian and German law, although for comparison, common law doctrine and the experience of other countries (including post-Soviet ones) are often used.

Keywords: Medical law, parties to a medical service contract, patient representation, basic obligations of a doctor.

Introduction

The regulation of relations between the patient and the medical service provider has great importance both for the parties themselves and for the state.^[1] The World Health Organization (WHO) emphasizes in its constitution that health care includes not only the existence of an effective health system, but also the ability to access it,^[2] which is only possible under the conditions of a relevant legal order.

In practice, the relationship between the physician and the patient is primarily regulated by a medical services contract.^[3] However, the formation of a specialized legal framework governing such contracts remains a significant challenge for Georgia, a country with a developing legal system. The legal doctrine in this field is still in the process of formation,^[4] which in practice often leads to ambiguity and creates a risk of unjustified infringement of the parties’ interests.

Considering the above, the main research question of this article is what fundamental legal principles and obligations should underlie the medical services contract in order to ensure high-quality medical care, contractual fairness, and equality between the parties. It should be taken into account that, in most cases, a patient’s decision to seek medical assistance is driven by the need to avoid a threat to their life or health. Consequently, in practice, the patient is effectively compelled to accept the contractual terms offered by the medical service provider, which are often aimed at transferring contractual risks to the patient and minimizing the physician’s liability. Therefore, it is essential to determine which obligations constitute the core duties of the parties to a medical services contract, which may not be excluded or limited by agreement, and what mechanisms should be established to ensure the genuine protection of the patient’s autonomy.

The above is particularly important in the case of minors and patients who lack the capacity to make informed decisions, in whose treatment process third parties are actively involved. In this regard, it is important to clarify to what extent a minor has the authority to decide independently on the receipt of medical services, and to what extent the parents, legal representatives, or relatives should be involved in the treatment process. It is also necessary to determine whether the consent of one parent is sufficient for the treatment of a minor, and how the medical service provider should act if the requirements of the patient’s legal representative do not correspond to the needs of treatment. These issues are also important in the case of patients who cannot make informed decisions.

It should be noted that, in the course of medical treatment, particular importance is attached to the patient’s informed consent, the duty of care, the obligation of confidentiality, and the maintenance of medical documentation. Accordingly, one of the main parts of this study is to determine the content and scope of these obligations.

Accordingly, this study aims to address the above-mentioned questions and to develop recommendations for improving the legal framework governing the relationship between the patient and the medical service provider, based on an analysis of their legal and factual status and a comparative examination of Georgian and foreign, primarily German, law.

The scientific novelty of the present study lies in its examination of the need to recognize the medical services contract as a distinct legal category, approached through both dogmatic and comparative legal analysis, with particular consideration of the German model. The study of this need is important not only for Georgia, but also for other countries whose laws do not separately regulate the medical service contract as a special type of contract. The novelty of the study is also manifested in the fact that, for the first time, an integrated analysis is made of the issue of the weak pre-contractual status of the patient, the authority of minors, and the legal protection of patients lacking the capacity to make informed decisions.

Accordingly, the study has considerable theoretical and practical significance. From a theoretical perspective, it examines, through a comparative legal approach, the subjects of the medical services contract, their interests, and their core obligations, issues that have not yet been fully explored in Georgian law. From a practical standpoint, the results of the research may serve as supporting and interpretative material for the refinement of judicial practice and the improvement of the legal framework.

Literature Review

Georgian legal doctrine is not distinguished by an abundance of scholarly research on patient rights or medical law. The existing literature mainly focuses on the problem of compensation for damage caused by medical malpractice.[5] Accordingly, less attention has been devoted to the contractual relationship between the patient and the medical service provider, and the existing studies address only specific elements of this relationship (e.g., informed consent, the protection of minors, and similar aspects).[6] Particularly few studies examine specific issues of medical law from a comparative legal perspective.[7] The German legal doctrine is comparatively more developed in this field. Following the 2013 legislative reform, paragraphs 630a–630h were added to the German Civil Code (BGB), thereby establishing a distinct legal framework for the medical services contract. German law regards the medical services contract as a specific type of agreement, as its performance depends on the provision of the service itself rather than the achievement of a particular result.[8] According to the prevailing view, a doctor is not a guarantor of results.^[9]  In this relationship, both legislation and legal doctrine place particular emphasis on the physician’s obligations of patient information,[10] care,[11] confidentiality, and the maintenance of medical documentation.[12]

The relationship between the patient and the medical service provider is regulated through judicial precedents in common law countries. For example, in the United Kingdom, several landmark cases have played a decisive role in this regard, including: Bolam v. Friern Hospital Management Committee (1957), Bolitho v. City and Hackney Health Authority (1997), Cassidy v. Ministry of Health (1957), and others. These precedents established the substantive content of the physician’s obligations and the standards for assessing their fulfillment. At the international level, the specification of physicians’ duties began with the Nuremberg Code, which first articulated the concept of informed consent. This was followed by the adoption of the International Code of Medical Ethics in 1949, which established standards of professional ethics.[13] Patient rights were further reinforced by the 1981 Lisbon Declaration on the Rights of the Patient[14] and the 1997 Oviedo Convention,[15] both of which are discussed in the present article.

In view of the above, the present study represents an attempt to conduct a comparative legal analysis of issues that have thus far been addressed only fragmentarily in Georgian legal literature, taking into account relevant foreign experience. Such an approach contributes to the institutional strengthening of medical law in Georgia at both the academic and practical levels. The comparison of Georgian law, as that of a post-Soviet transitional country, with European legal approaches is of interest for further research not only within the European context but also in the broader study of post-Soviet legal systems.

Methodology

The central methodological basis of this research is the comparative legal method. The study primarily compares the Georgian and German models. The choice of the German model is justified by the fact that, among the continental European legal systems (e.g., France, Italy, and others), it is the one most closely aligned with Georgian law. It is noteworthy that the Georgian Civil Code was developed based on the reception of the German Civil Code (BGB). Consequently, the German model is the most compatible with the Georgian legal system, which makes this comparison both scientifically sound and contextually relevant.

The study also uses the normative-dogmatic method, which allows for the interpretation of existing legal norms on the basis of a systematic framework of legal dogmatics.

The inductive and deductive methods enable the transition from general principles to specific cases and, conversely, the derivation of general conclusions from the analysis of individual instances.

The systematic and logical analysis methods are applied to determine the interrelation of contractual elements, specifically, to examine the obligations of patient information, care, confidentiality, and medical documentation within a unified framework.

1. Patient

According to German law, a patient is a person to whom a healthcare provider has promised to provide medical services.[16] He or she can only be a human,[17] not an animal, as the regulation of animal treatment does not fall within the scope of medical law.[18]

Georgian legislative acts provide different definitions of the term “patient”,[19] which may be considered a legislative gap. In order to ensure a uniform standard, it is advisable to establish the definition provided for in Article 4 of the Law of Georgia on “Patient Rights”. According to this norm, a patient is any person who, regardless of his or her health condition, uses needs or intends to use the services of the healthcare system.

The provider of medical services has legal, moral, and ethical obligations towards the patient,[20] which mainly serve, on the one hand, to protect the patient’s right to life and health, and on the other hand, to ensure his or her autonomy.[21]

Patient autonomy is the right of the patient to determine independently all matters related to the provision of medical care.[22] In practice, the main barrier to the full realization of this right is the patient’s weak pre-contractual position. Considering that receiving medical services is often essential to protect the patient’s life and health, the patient is practically compelled to agree to the contractual terms offered by the medical service provider, which makes the patient the weaker party to the contract.

In order to improve patients’ rights, amendments were made to the German Civil Code in 2013.[23] This reform mainly recognized the principles previously established in German case law,[24] most of which concerned the obligation to inform patients[25] and created a legislative basis for the protection of patients’ rights.

Post-Soviet countries are trying to balance the dominant position of medical service providers with different mechanisms. For example, the Code of Administrative Offenses of the Russian Federation provides for administrative liability for including conditions in contracts that violate the legally established rights of consumers, including patients.[26]

In Georgia, the function of controlling the content of the terms of a medical service contract is primarily carried out by the courts.[27] To define the rights and obligations of the parties and eliminate legal uncertainty, it would be advisable to regulate the medical service contract as a special type of contract under the Civil Code, as is the case in other European countries (e.g., Germany).[28] This would contribute to the codification of private legal relations within a single act and enhance the standard of protecting the equality of the parties’ rights.

1.2 Minor patient

Public interest is high when it comes to the treatment of minors. The question of whether a minor has the right to receive medical services independently remains a subject of legal debate.[29] In this regard, ambiguity also exists in Georgian law.

Article 41 paragraph 3 of the Law of Georgia on “Patients’ Rights” grants a minor over the age of 16 (who, in the opinion of the medical service provider, is capable of adequately assessing his or her own state of health) the right to give informed consent or refusal to medical treatment, whereas under Article 14 of the Civil Code of Georgia, a person under the age of 18 is deemed to have limited legal capacity. Accordingly, any transaction concluded by him or her is subject to approval[30] by the legal representatives.[31]

Thus, a minor needs the consent of a legal representative to receive medical services.[32] The exception is such personal and sensitive issues defined by law, in which parents’ intervention may further worsen the minor’s condition. For comparison, the institution of “Gillick Competence” is established in the common law doctrine, according to which a minor is entitled to independently make a decision on receiving medical services if he or she has the ability to properly understand the issue.[33]

According to the prevailing view, a parent or other legal representative must act in the best interests of the minor.[34] If, in the opinion of the medical service provider, the decision of the parent or other representative does not serve the best interests of the patient, he or she may apply to the court, or in cases of emergency, act based on medical necessity.[35] The same rule applies in the absence of a parent or other legal representative.[36]

In the case of Glass v. the United Kingdom (2004), the European Court of Human Rights found a violation of the right to respect for private and family life. The Court held that the doctors, considering the minor to be in a terminal stage, administered a strong dose of morphine to the patient against the mother’s wishes. Although this may have been medically justifiable, the Court’s finding of a violation was grounded in the fact that the doctors acted unilaterally, without seeking judicial authorization, despite the parent’s refusal.[37]

Regarding the treatment of a minor, it also remains to be clarified whether the consent of both parents is required. In this context, there is a tension between, on the one hand, the parents’ right to be equally involved in matters concerning the treatment of their minor children and, on the other hand, the need to reduce medical bureaucracy. This dilemma is resolved by German doctrine, according to which the consent of both parents is required only in cases of interventions of particular complexity and importance, determined in advance; otherwise, the consent of one parent/legal representative is presumed.[38] This is a practical and effective way to solve the problem. Accordingly, the view regarding the advisability of reflecting the above approach in Georgian legislation should be supported.[39]

1.3 Patient lacking the capacity to make informed decisions

People may find themselves in situations where they are deprived of the ability to express their will,[40] in which they are unable to independently make decisions related to treatment.[41] From a private law perspective, a patient lacking the capacity to make informed decisions may be compared to a young minor (a person under the age of seven). The difference is that in this case, the person is incapacitated due to age,[42] while a patient lacking the ability to make informed decisions may also be an adult who, due to an accident or mental condition, is deprived of the ability to express a true will.[43]

In the United Kingdom, the treatment of patients in this category is regulated by a special legal act - the Mental Capacity Act 2005. It sets out the relevant criteria for assessing a person’s decision-making capacity and establishes that, in the absence of such capacity, any intervention must be carried out in the patient’s best interests, taking into account his or her past wishes, beliefs, and the views of relatives.[44]

In Georgia, the norms related to the treatment of patients lacking the capacity to make informed decisions are not consolidated in a single legal act. Decisions concerning the treatment of patients in this category are made taking into account the will they expressed in the past (when they had the capacity to make informed decisions), and in the absence of such will, based on the informed consent of their relative or legal representative.[45] In case of a conflict between the decisions of a relative and a legal representative, the will of the legal representative has priority. The involvement of relatives in decisions concerning the provision of medical services to the patient depends on their priority.[46] The decision of a patient’s legal representative or relative is binding on the medical service provider to the extent applicable in the case of a minor, as discussed above.

2. Medical Service Provider

The provider of medical services is a natural or legal entity[47] that performs any manipulation or procedure on a patient for diagnosis, treatment, prevention, or medical rehabilitation.[48] The interest existing in legal doctrine toward the medical service provider as a party to the contract is conditioned by the high social significance of medical services. In view of the above, certain obligations are imposed on the medical service provider, which ensure the provision of quality treatment and the protection of contractual equality between the parties.

2.1 Obligation to inform the patient

Informing the patient is part of the concept of informed consent,[49] which was first declared in the Nuremberg Code of 1947.[50] Later, this principle was reflected in the Lisbon Declaration on the Rights of the Patient, adopted by the World Medical Association in 1981.[51] Informing the patient, as a mandatory prerequisite for any medical intervention, is also provided for in the Oviedo Convention of 1997.[52]

The duty to inform means that, before medical services are provided, the patient must receive clear and complete information about the planned preventive, diagnostic, treatment, and rehabilitation services, as well as about alternative options, possible risks, expected effectiveness, the consequences of refusing treatment, the available resources, the ways these services can be received, their costs and reimbursement methods, the patient’s rights and duties, and the identity and professional background of the medical provider. After treatment begins, the patient must also be informed about the results of medical tests, the diagnosis, the progress of treatment, and the likely prognosis.[53]

It is essential that patients are informed in terms they can easily understand,[54] without long or confusing sentences. The information should be clear, concise, and easy to follow.[55] For example, according to the recommendations of the Coalition for Reducing Bureaucracy in Clinical Trials, the information provided to obtain informed consent should not exceed 1,000 words.[56]

The duty to inform is also established in German law.[57] Its content is defined in Section 630e of the German Civil Code, according to which the healthcare provider is obliged to inform the patient of all essential circumstances necessary for obtaining consent.[58] This primarily concerns purely medical issues. However, the scope of information to be provided to the patient is practically the same in both Georgian and German law.

The duty to inform does not exist if the patient has refused to receive the information, if there is a justified doubt that giving such information would seriously harm the patient’s health (unless the patient insists on being informed),[59] or if urgent medical intervention is needed.[60]

2.2 Duty of care

The term “duty of care” is not expressly provided for in Georgian legislation. however, its content derives from the patient’s right to treatment and care,[61] as well as from the duty of diligence established under Article 316(2) of the Civil Code of Georgia.[62] In medical law, the duty of care represents the obligation of the healthcare provider to exercise, toward the patient, a degree of caution consistent with a high professional standard, such as would be demonstrated by another competent doctor practicing in the same field.[63] It includes the core duties of the healthcare provider, which are: looking after the patient, making a diagnosis, referring to another specialist (if necessary), providing treatment, and giving guidance.[64] A special feature of the duty of care is that both the medical institution and the treating doctor owe it separately to the patient.[65]

In practice, it is particularly important to determine in which cases the duty of care is considered to have been breached. In common law countries (for example, the United Kingdom), the ‘Bolam standard’ is applied for this assessment. According to this standard, a doctor’s liability is evaluated based on whether he or she acted in accordance with a reasonably accepted and authoritative professional practice.[66] If the doctor’s conduct is consistent with the practice accepted by a responsible and competent group of specialists, he or she is not obliged to compensate for any damage.[67] The “Bolam standard” was further refined in the case of Bolitho v. City and Hackney Health Authority (1997), decided by the House of Lords in the United Kingdom, where it was established that, in addition to compliance with professional standards, the doctor must also justify why a particular method of treatment was chosen.[68]

In Georgia, the “Bolam standard” is not directly applied; however, judicial practice also links the determination of a doctor’s liability to actions inconsistent with professional standards and to the failure to achieve medical objectives.[69] A similar approach is established in German law.[70] This demonstrates a shared understanding of the content of the duty of care across different legal systems.

2.3 Duty of confidentiality

Information related to medical services concerns the most private sphere of a person, namely his or her life and health.[71] Therefore, safeguarding its confidentiality is a fundamental duty of the healthcare provider.[72] This duty derives from the fundamental right to respect for private and family life[73] and continues to apply even after the patient’s death.[74]

In the European Union, the General Data Protection Regulation (GDPR) has been in force since 25 May 2018, which, among other issues, regulates the processing of health-related data.[75] In order to approximate Georgian legislation to the regulations provided for by the GDPR, on 14 June 2023, the Parliament of Georgia adopted the Law of Georgia on Personal Data Protection,[76] which classified health-related data as a special category of data and introduced monetary fines for its unlawful processing.[77] For comparison, under Section 203 of the German Criminal Code, breach of confidentiality is subject to criminal liability.[78]

In practice, keeping information confidential is especially difficult when, because of the patient’s health condition, other people take part in treatment decisions. In such cases, it is important to keep a balance between protecting the patient’s privacy and avoiding unnecessary bureaucracy.

It should be noted that confidentiality is not absolute and may be limited in certain cases.[79] For example, the European Court of Human Rights did not find a violation in a case where medical staff shared information about a patient’s HIV-positive status with another hospital employee to protect safety.[80]

In Georgia, disclosing confidential information is allowed in certain cases: if the patient has given consent; if keeping the information secret puts the life or health of another identified person at risk; if the data is used for teaching or research purposes in a way that does not reveal the patient’s identity; if the information concerns possible violence against women or domestic violence and there is a risk of repetition (in this case it is shared only with the relevant state authorities);[81] if there is a reasonable suspicion of a disease subject to mandatory registration, the information is shared with other medical staff involved in treatment; if disclosure is required for forensic examination; or if law enforcement requests it under a court decision.[82]

The duty of confidentiality is not only a guarantee of privacy; it also helps build trust between doctor and patient,[83] which is an important factor for the success of medical care.

2.4 Duty to produce medical documentation

In Georgia, doctors and other healthcare personnel are required to keep records in medical documentation in accordance with the established rules. The rules for keeping medical documentation are approved by a subordinate legal act – a ministerial order.[84] In Germany, the obligation to produce medical records is defined in Section 630f of the Civil Code. [85] It should be noted that the purpose of keeping medical records in Georgia and other countries is essentially the same and is related to the following objectives:

• Ensuring that the patient is informed at every stage of treatment, which, as already noted, is one of the doctor’s main duties;


• Ensuring an uninterrupted treatment process. Medical documentation enables the doctor to review the patient’s history and continue consistent treatment, which is especially important in the event of a change of doctor;


• Ensuring that healthcare personnel carry out their professional activities to a high standard. Knowing that the provided medical service is subject to documentation and control encourages doctors to deliver treatment using the best methods;[86]


• Assessing the quality of treatment and providing evidence for both parties, which is especially important for determining the liability of the medical service provider;[87]


• Ensuring epidemiological and public health. Producing medical documentation helps record statistics on the spread of diseases, which is important for planning preventive measures;


• Supporting medical research and education, which largely depends on the availability of individuals’ medical data (in a depersonalized form);[88]


• The effective functioning of the health insurance system and control of payments, important for avoiding unnecessary medical procedures and optimizing costs.

Thus, producing medical documentation is not only an administrative requirement. It has an important means for ensuring high-quality care and protecting the interests of parties. 

Conclusion

In Georgia, the legal norms regulating the relationship between the patient and the medical service provider are spread across different acts. It is advisable to consolidate them into a single legal framework, which will promote the establishment of a unified approach, the traceability of norms, and reduce the risks of conflict between them.

In practice, an important problem is that, compared to the medical service provider, the patient has less ability to negotiate the terms that are favorable to him or her (negotiation power).[89] As a result, the patient usually accepts the terms offered to receive medical services. Considering this, it is important that the rights essential for the patient in receiving medical services be established by law through imperative rather than discretionary norms, which excludes the possibility of limiting them by contract. This is essential for safeguarding patient autonomy and balancing the dominant position of the medical service provider. Such an approach may also prove useful for other post-Soviet countries with transitional legal systems, where the legislation and doctrine regulating the relationship between the patient and the physician are still in the process of formation.

With regard to the parties to a medical service contract, it is unclear whether a minor patient over the age of 16 has the authority to conclude the contract independently. Article 41, paragraph 3 of the Law of Georgia on “Patient Rights” and Articles 14 and 63 of the Civil Code of Georgia are in conflict. According to the first of them, informed consent expressed by a minor patient over the age of 16 is sufficient to receive medical services, if, in the opinion of the medical service provider, he or she properly understands his or her health condition, while the second of them additionally requires the consent of a parent/legal representative. From the perspective of protecting the best interests of the minor, it is advisable that the above-mentioned conflict of norms be resolved in favor of the regulation established by the Civil Code. An opposite view, which is recognized in common law doctrine, is that a minor may be considered competent if he or she has sufficient ability to adequately perceive and understand the essence of the specific matter.[90]

Another issue is whether the consent of only one parent or legal representative is sufficient. According to the German approach, the consent of both parents or legal representatives is required only in cases involving particular risks.[91] Specifying this matter is also important for Georgian law.

With regard to the treatment of a patient lacking decision-making capacity, it is advisable to apply the rules that govern the treatment of minors (a person under the age of seven), with the difference that in this case, greater importance is attached to respecting the patient’s past wishes and views.

To make healthcare accessible and protect patient rights, the medical service provider must, no matter what type of medical intervention is performed, inform the patient, provide proper care, keep information confidential, and keep medical records. If these duties are violated, legal liability arises.

The content of the obligation to inform the patient is similar in Georgian and German law and covers both medical and administrative issues. Its purpose is to address the information asymmetry between the doctor and the patient and to ensure the full realization of patient autonomy.

The duty of care holds a central place in the treatment process. It means that the medical services given to the patient must be of good quality and follow accepted medical practice. This duty applies once the medical provider has agreed to treat the patient.[92]

In the relationship between the parties, confidentiality and the duty to produce medical records play an important role. Confidentiality ensures the protection, within the limits defined by law, of information disclosed both during and after the treatment process. Producing medical records helps provide consistent treatment and makes it easier to check the accuracy of the services delivered, which is important for determining responsibility and protecting the rights of the parties.

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Legal Acts:

Council of Europe. (1997). Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine. <https://rm.coe.int/168007cf98?utm_source=chatgpt.com>;

Council of Europe. (1997). Recommendation No. R (97) 5 of the Committee of Ministers to Member States on the Protection of Medical Data. Adopted by the Committee of Ministers on 13 February 1997 at the 584^th meeting of the Ministers’ Deputies. <https://rm.coe.int/16804da198>;

German Criminal Code (1998). Violation of private secrets. Section 203. Federal Ministry of Justice. <https://www.gesetze-im-internet.de/englisch_stgb/englisch_stgb.html>;

Law of Georgia on Health Care (1997). Legislative Herald of Georgia. <https://new.matsne.gov.ge/ka/document/view/29980?publication=58>;

Law of Georgia on Medical Practice (2001). Legislative Herald of Georgia. <https://matsne.gov.ge/ka/document/view/15334?publication=32>;

Law of Georgia on Patients’ Rights (2000). Legislative Herald of Georgia. <https://matsne.gov.ge/ka/document/view/16978?publication=15>;

Law of Georgia on Personal Data Protection (2023). Legislative Herald of Georgia. <https://matsne.gov.ge/document/view/5827307?publication=5>;

World Health Organization. (2006). Constitution of the World Healthcare Organization. <https://apps.who.int/gb/bd/PDF/bd47/EN/constitution-en.pdf?ua=1>;

World Medical Association. (1981). Declaration of Lisbon on the Right of the Patient. <https://www.wma.net/policies-post/wma-declaration-of-lisbon-on-the-rights-of-the-patient/>;

World Medical Association. (2022). WMA International Code of Medical Ethics. <https://www.wma.net/policies-post/wma-international-code-of-medical-ethics/>.

Court Cases:

European Court of Human Rights. (2003). Decision in the case of Y v. Turkey;

European Court of Human Rights. (2004). Decision in the case of Glass v. the United Kingdom;

European Court of Human Rights. (2006). Decision in the case of L.L. v. France;

House of Lords. (1951). Decision in the case of Cassidy v. Ministry of Health;

House of Lords. (1957). Decision in the case of Bolam v. Friern Hospital Management Committee;

House of Lords. (1997). Decision in the case of Bolitho v. City and Hackney Health Authority;

Supreme Court of Georgia, Chamber of Civil Cases. (April 30, 2025). Decision № AS-1280-2023;

Supreme Court of Georgia, Chamber of Civil Cases. (March 13, 2025). Decision №AS-962-2024.

Other Supporting Materials:

Coalition for Reducing Bureaucracy in Clinical Trials. (2021). Recommendations of the Coalition for Reducing Bureaucracy in Clinical Trials. <https://bureaucracyincts.eu/>;

Parliament of Georgia. (2019). Explanatory note to the draft law on Personal Data Protection. <https://info.parliament.ge/file/1/BillReviewContent/222087?>.

Footnotes

[1] Blanchard, C. N. (1921). Medical Law. Loyola Law Journal (New Orleans), 2(3), 17.

[2] World Health Organization. (2006). Constitution of the World Healthcare Organization. <https://apps.who.int/gb/bd/PDF/bd47/EN/constitution-en.pdf?ua=1>.

[3] Labariega Villanueva P.A. (2005). Medical Attention Contract. Juridical Nature. Mexican law review, January-June. <http://info8.juridicas.unam.mx/cont/mlawr/3/arc/arc9.htm#N*>.

[4] Rusiashvili, G., Kvantaliani, N., Zarandia, T. (2022). Concept of the Journal of Medical Law and Management. Journal of Medical Law and Management, 1, 4.

[5] Pepanashvili, N. (2016). Compensation for Damage Caused by a Medical Institution (Doctoral Dissertation). 1-240. <https://press.tsu.ge/data/image_db_innova/samartal/nino_pepanashvili.pdf>; Kvantaliani, N. (2014). Patient Rights and the Grounds of Civil Liability of Physicians. World of Lawyers.

[6] Chavleshivili, G. (2023). Informed consent in the medical treatment of minors. Journal of Medical Law and Management, 2(3), 84-103; Gelashvili, I. (2024). Protection of patients lacking the capacity to give consent. Journal of Medical Law and Management, 2(5), 58-82.

[7] Bichia, M. (2019). Features of Protecting the Patient’s Personal Autonomy and of Giving Informed Consent (Georgian and European Approaches). Law and the World, 12, 51-67.

[8] Dannemann, G., Schulze, R. (2020). German Civil Code. Volume I: Books 1-3(§§1-1296), Article-by-Article Commentary. С.H. Beck & Nomos, 1149-1150.

[9] Prütting, J. (2023). Germany. In Nys, H. (Ed.), International Encyclopedia of Laws: Medical Law (p. 68). Kluwer Law International.

[10] Buchner, B. (2020). Informed consent in Germany. In Vansweevelt, T., Glover-Thomas, N. (Eds.), Informed consent and health: A global analysis (pp. 216-234). Edward Elgar Publishing. <https://doi.org/10.4337/9781788973427.00018>.https://doi.org/10.4337/9781788973427.00018

[11] Hagenloch, U. (2024). Medical Law News in Germany. Important Trends in German Judicial Practice in the First Half of 2022. Journal of Medical Law and Management, 1. 1-21.

[12] Lytvynenko, A. A. (2020). A Right of Access to Medical Records: The Contemporary Case Law of the European Court of Human Rights and the Jurisprudence of Germany. Athens Journal of Law, 6(1), 103-122. <https://doi.org/10.30958/ajl.6-1-6>.

[13] World Medical Association. (2022). WMA International Code of Medical Ethics. <https://www.wma.net/policies-post/wma-international-code-of-medical-ethics/>.

[14] World Medical Association. (1981). Declaration of Lisbon on the Right of the Patient. <https://www.wma.net/policies-post/wma-declaration-of-lisbon-on-the-rights-of-the-patient/>.

[15] Council of Europe. (1997). Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine. <https://rm.coe.int/168007cf98?utm_source=chatgpt.com>.

[16] Bakradze, F. (2022). GCС’s- 630a-630h paragraphs – Medical service contract. Journal of Medical Law and Management, 1, 112.

[17] Dannemann, G., Schulze, R. (2020). German Civil Code. Volume I: Books 1-3(§§1-1296), Article-by-Article Commentary. С.H. Beck & Nomos, 1149-1150.

[18] Hagenloch, U. (2024). Medical Law News in Germany. Important Trends in German Judicial Practice in the First Half of 2022. Journal of Medical Law and Management, 1, 3.

[19] Law of Georgia on Health Care (1997). Article 3(r). Legislative Herald of Georgia. <https://new.matsne.gov.ge/ka/document/view/29980?publication=58>; Law of Georgia on Patients’ Rights (2000). Article 4(d). Legislative Herald of Georgia. <https://matsne.gov.ge/ka/document/view/16978?publication=15>.

[20] Prütting, J. (2023). Germany. In Nys, H. (Ed.), International Encyclopedia of Laws: Medical Law (p. 74). Kluwer Law International.

[21] Wellman, C. (2005). Medical Law and Moral Rights. Springer, 195. <https://doi.org/10.1007/1-4020-3752-X>.

[22] Law of Georgia on Health Care (1997). Article 3(a). Legislative Herald of Georgia. <https://new.matsne.gov.ge/ka/document/view/29980?publication=58>.

[23] Prütting, J. (2023). Germany. In Nys, H. (Ed.), International Encyclopedia of Laws: Medical Law (p. 70). Kluwer Law International.

[24] Hagenloch, U. (2023). Important trends in German judicial practice in the field of medical law in 2021. Journal of Medical Law and Management, 2, 1.

[25] Hagenloch, U. (2023). Patient information in Germany. Journal of Medical Law and Management, 2(3), 3.

[26] Matytsin, D. E., Plaksunova, T. A. (2020). The content of the contract for the provision of paid medical services: Theoretical and applied analysis. Issues of Private Law Regulation: History and Modernity, 19(4), 91. <https://doi.org/10.15688/lc.jvolsu.2020.4.12>.

[27] Supreme Court of Georgia, Chamber of Civil Cases. (April 30, 2025). Decision № AS-1280-2023.

[28] Dannemann, G., Schulze, R. (2020). German Civil Code. Volume I: Books 1-3(§§1-1296), Article-by-Article Commentary. С.H. Beck & Nomos, 1149-1162.

[29] George, R. (2024). Medical Decision-Making about Children. In Wards of Court and the Inherent Jurisdiction. Hart Publishing, 123. <http://dx.doi.org/10.5040/9781509972173.ch-008>.

[30] Gelashvili, I. (2024). Protection of patients lacking the capacity to give consent. Journal of Medical Law and Management, 2(5), 61.

[31] Hagger, L. (2009). Parental Responsibility and Children’s Health Care Treatment. Responsible Parents and Parental Responsibility. Hart Publishing, 185-186.

[32] Gelashvili, I. (2024). Protection of patients lacking the capacity to give consent. Journal of Medical Law and Management, 2(5), 61.

[33] Chavleshivili, G. (2023). Informed consent in the medical treatment of minors. Journal of Medical Law and Management, 2(3), 97-98.

[34] Hoppe, N., Moia, J. (2014). Medical Law and Medical Ethics. Cambridge University Press, 122.

[35] Stetsenko, S. G. (2006). Medical error and accidents in the practice of healthcare institutions: Legal aspects. Expert-Criminalist, 2, 31.

[36] Chavleshivili, G. (2023). Informed consent in the medical treatment of minors. Journal of Medical Law and Management, 2(3), 95.

[37] European Court of Human Rights. (2004). Decision in the case of Glass v. the United Kingdom.

[38] Hagenloch, U. (2023). Patient information in Germany. Journal of Medical Law and Management, 2(3), 42-43.

[39] Chavleshivili, G. (2023). Informed consent in the medical treatment of minors. Journal of Medical Law and Management, 2(3), 95.

[40] Levy, S. (2009). Cultural Influences on Medical Law. Medicine and Law, 28(4), 595-596.

[41] Hajek, O. (2003). Lord Denning and Medical Law. Common Law Review, 5, 27.

[42] Chanturia, L. (2011). General part of civil law. Samartali, 180.

[43] Koniaris, V. Th., Konstantinidou, E. S. (2023). Greece. In Nys, H. (Ed.), International Encyclopedia of Laws: Medical Law (p. 132). Kluwer Law International.

[44] Hoppe, N., Moia, J. (2014). Medical Law and Medical Ethics. Cambridge University Press, 112.

[45]Law of Georgia on Health Care (1997). Article 11. Legislative Herald of Georgia. <https://new.matsne.gov.ge/ka/document/view/29980?publication=58>.

[46]Law of Georgia on Patients’ Rights (2000). Article 4 (v and e). Legislative Herald of Georgia. <https://matsne.gov.ge/ka/document/view/16978?publication=13>.

[47] Mulheron, R. (2017). Duties in Contract and Tort. In Principles of Medical Law. Oxford University Press, 104-105.

[48] Law of Georgia on Patients’ Rights (2000). Article 4 (v and z). Legislative Herald of Georgia. <https://matsne.gov.ge/ka/document/view/16978?publication=15>.

[49] Dannemann, G., Schulze, R. (2020). German Civil Code. Volume I: Books 1-3(§§1-1296), Article-by-Article Commentary. С.H. Beck & Nomos, 1155.

[50] Myronova, G. (2022). The Doctrine of the Patient’s Personal Autonomy in Absolute Legal Relations: Directions of Improvement of the Legislation of Ukraine. In Ukrainian Healthcare Law in the Context of European and International Law (p. 101). Springer. <https://doi.org/10.1007/978-3-031-05690-1_6>.

[51] World Medical Association. (1981). Declaration of Lisbon on the Right of the Patient. <https://www.wma.net/policies-post/wma-declaration-of-lisbon-on-the-rights-of-the-patient/>.

[52] Council of Europe. (1997). Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine. <https://rm.coe.int/168007cf98?utm_source=chatgpt.com>.

[53] Law of Georgia on Patients’ Rights (2000). Article 18(1). Legislative Herald of Georgia. <https://matsne.gov.ge/ka/document/view/16978?publication=15>.

[54] Dughishvili, G. (2022). Informed consent in medicine. Journal of Medical Law and Management, 1, 126.

[55] Nys, H. (2024). European Union Health Law. In Nys, H. (Ed.), International Encyclopedia of Laws: Medical Law (p. 17). Kluwer Law International.

[56] Coalition for Reducing Bureaucracy in Clinical Trials. (2021). Recommendations of the Coalition for Reducing Bureaucracy in Clinical Trials. <https://bureaucracyincts.eu/>.

[57] Bakradze, F. (2022). GCС’s- 630a-630h paragraphs – Medical service contract. Journal of Medical Law and Management, 1, 114.

[58] Dannemann, G., Schulze, R. (2020). German Civil Code. Volume I: Books 1-3(§§1-1296), Article-by-Article Commentary. С.H. Beck & Nomos, 1154-1155.

[59]Law of Georgia on Patients’ Rights (2000). Article 20. Legislative Herald of Georgia. <https://matsne.gov.ge/ka/document/view/16978?publication=15>.

[60] Dannemann, G., Schulze, R. (2020). German Civil Code. Volume I: Books 1-3(§§ 1-1296), Article-by-Article Commentary. С.H. Beck & Nomos, 1155-1156.

[61] Law of Georgia on Patients’ Rights (2000). Chapter II. Legislative Herald of Georgia. <https://matsne.gov.ge/ka/document/view/16978?publication=15>.

[62] Vashakidze, G., Gelashvili, I., Baghishvili, E., Rusiashvili, G., Aladashvili, A., Meskhishvili, K., Mots’onelidze, N., Batlidze, G., Jorbenadze, S., Gatserelia, A., Svanadze, G., Robakidze, I. (2019). Commentary on the Civil Code of Georgia, Book III, Chanturia, L. (Ed.), 25.

[63] Hoppe, N., Moia, J. (2014). Medical Law and Medical Ethics. Cambridge University Press, 48.

[64] Davies, C. E., Shaul, R. Z. (2010). Physicians’ legal duty of care and legal right to refuse to work during a pandemic. CMAJ: Canadian Medical Association Journal, 182(2), 167. <https://doi.org/10.1503/cmaj.091628>.

[65] Devereux, J., Beran, R. G. (2022). Medical Negligence Law in Australia. In Medical Liability in Asia and Australasia (p. 11). Springer. <https://doi.org/10.1007/978-981-16-4855-7>.

[66] House of Lords. (1957). Decision in the case of Bolam v. Friern Hospital Management Committee.

[67] Bryden, D., Storey, I. (2011). Duty of care and medical negligence. Continuing Education in Anaesthesia, Critical Care & Pain, 11(4), 125. <https://doi.org/10.1093/bjaceaccp/mkr016>.

[68] House of Lords. (1997). Decision in the case of Bolitho v. City and Hackney Health Authority.

[69] Supreme Court of Georgia, Chamber of Civil Cases. (March 13, 2025). Decision №AS-962-2024.

[70] Dannemann, G., Schulze, R. (2020). German Civil Code. Volume I: Books 1-3(§§1-1296), Article-by-Article Commentary. С.H. Beck & Nomos, 1149-1150.

[71] Hoppe, N., Moia, J. (2014). Medical Law and Medical Ethics. Cambridge University Press, 16.

[72] World Medical Association. (2022). WMA International Code of Medical Ethics. <https://www.wma.net/policies-post/wma-international-code-of-medical-ethics/>.

[73] Hoppe, N., Moia, J. (2014). Medical Law and Medical Ethics. Cambridge University Press, 21.

[74] European Court of Human Rights. (2006). Decision in the case of L.L. v. France.

[75] Prütting, J. (2023). Germany. In Nys, H. (Ed.), International Encyclopedia of Laws: Medical Law (p. 76). Kluwer Law International.

[76] Parliament of Georgia. (2019). Explanatory note to the draft law on Personal Data Protection. <https://info.parliament.ge/file/1/BillReviewContent/222087?>.

[77] Law of Georgia on Personal Data Protection (2023). Definitions, Article 3(b–g). Processing of special category data without the grounds provided by this Law, Article 68. Legislative Herald of Georgia. <https://matsne.gov.ge/document/view/5827307?publication=5>.

[78] German Criminal Code (1998). Violation of private secrets. Section 203. Federal Ministry of Justice. <https://www.gesetze-im-internet.de/englisch_stgb/englisch_stgb.html>.

[79] Herring, J. (2022). Medical Law and Ethics (9^th ed.). Oxford University Press, 305.

[80] European Court of Human Rights. (2003). Decision in the case of Y v. Turkey.

[81] Law of Georgia on Patients’ Rights (2000). Article 20(1). Legislative Herald of Georgia. <https://matsne.gov.ge/ka/document/view/16978?publication=15>.

[82] Law of Georgia on Medical Practice (2001). Confidentiality of Information. Article 48. Legislative Herald of Georgia. <https://matsne.gov.ge/ka/document/view/15334?publication=32>.

[83] Semyonov-Tal, K. (2024). Keeping medical information safe and confidential: A qualitative study on perceptions of Israeli physicians. Israel Journal of Health Policy Research, 13, 2. <https://doi.org/10.1186/s13584-024-00641-9>.

[84] Law of Georgia on Health Care (1997). Article 43. Legislative Herald of Georgia. <https://new.matsne.gov.ge/ka/document/view/29980?publication=58>.

[85] Dannemann, G., Schulze, R. (2020). German Civil Code. Volume I: Books 1-3(§§1-1296), Article-by-Article Commentary. С.H. Beck & Nomos, 1149-1150.

[86] Prütting, J. (2023). Germany. In Nys, H. (Ed.), International Encyclopedia of Laws: Medical Law (p. 83). Kluwer Law International.

[87] Abdelkader, Y. (2025). Towards a Special Compensation System Aligned with the Unique Nature of Civil Liability for Medical Applications of Genetic Engineering. Law and World, 34, 45. <https://doi.org/10.36475/L.A.W.14>.

[88] Council of Europe. (1997). Recommendation No. R (97) 5 of the Committee of Ministers to Member States on the Protection of Medical Data. Adopted by the Committee of Ministers on 13 February 1997 at the 584^th meeting of the Ministers’ Deputies. <https://rm.coe.int/16804da198>.

[89] Dobrijevic, G., Stanisic, M., Masic, B. (2011). Sources of negotiation power: An exploratory study. South African Journal of Business Management, 42(2), 35-36. <https://doi.org/10.4102/sajbm.v42i2.493>.

[90] Chavleshivili, G. (2023). Informed consent in the medical treatment of minors. Journal of Medical Law and Management, 2(3), 97-98.

[91] Hagenloch, U. (2023). Patient information in Germany. Journal of Medical Law and Management, 2(3), 42-43.

[92] House of Lords. (1951). Decision in the case of Cassidy v. Ministry of Health.