Legal Problems in Biomedicine
Study Course Implementer
Dzirciema street 16, Rīga, szf@rsu.lv
About Study Course
Objective
The aim of the study course is to develop students’ in-depth understanding of current biomedical law problems and the ability to critically analyse them in the context of Latvian, European Union and international law, human rights and bioethics, as well as to legally justify solutions to legal challenges posed by the development of biomedicine and new technologies.
Preliminary Knowledge
Medical law, human rights, civil law and criminal law, as well as understanding of the application of legal norms and analysis of legal sources.
Learning Outcomes
Knowledge
1.Students will gain in-depth knowledge of the principles of biomedical law, legal sources and their interaction with human rights and bioethics in the Latvian, European Union and international legal framework.
Examination
2.Students will gain in-depth knowledge of the legal framework for the use of the human body and biomaterials, organ and tissue transplantation, biobank operations, reproductive medicine, and issues related to the beginning and end of human life.
3.Students will gain in-depth knowledge of the legal challenges of new biomedical technologies, including artificial intelligence, human enhancement, biohacking, precision medicine, digital twins, health data and their secondary use.
Examination
Skills
1.Students will acquire the skills to identify and critically analyse biomedical law issues by applying Latvian, European Union and international legal sources and case law.
2.Students will acquire the skills to legally and argumentatively analyse biomedical law cases, identify the rights and legal risks of the parties involved, and formulate justified solutions to the problem.
3.Students will acquire the skills to evaluate the compliance of the existing legal framework with the development of biomedicine, digital health and new technologies and to develop legally justified proposals for improving the framework.
Examination
Competences
1.Students will be able to independently and responsibly evaluate complex biomedical legal issues, integrating the principles of legal science, human rights and bioethics.
2.Students will be able to independently formulate and argue a legally and ethically justified position in situations where it is necessary to balance personal autonomy, human dignity, fundamental rights, public interest and biomedical development.
Examination
3.Students will be able to critically evaluate the legal risks created by the development of biomedicine and new technologies and independently offer solutions to new and legally complex situations.
Assessment
Individual work
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Title
|
% from total grade
|
Grade
|
|---|---|---|
|
1.
E-learning and knowledge test |
30.00% from total grade
|
10 points
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Students independently watches the e-lecture posted in E-studies and gets acquainted with the study materials attached to it. After mastering the e-lecture, the student completes an electronic knowledge test within the time limit set by the lecturer. |
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Examination
|
Title
|
% from total grade
|
Grade
|
|---|---|---|
|
1.
Attendance |
20.00% from total grade
|
Test
|
|
Students attend the study course classes according to the study schedule and register their participation in the E-studies in accordance with the established procedure. During the classes, the student participates in discussions, analysis of legal situations and other tasks set by the lecturer. In case of justified absence, the student acquires the missed study content and performs the compensatory task set by the lecturer. Attendance is a mandatory requirement for completing the study course and a prerequisite for successfully completing the course. |
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|
2.
Examination |
50.00% from total grade
|
10 points
|
|
The final exam is an individual and in-person multiple-choice test on the entire content of the study course. The test includes closed-type questions with one or more correct answers according to the indication of each question. |
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Study Course Theme Plan
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Lecture
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Modality
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Location
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Contact hours
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|---|---|---|
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On site
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Auditorium
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2
|
Topics
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Human body and biomaterials: transplantation of organs and use of tissues
Description
The topic will analyze the legal status of the human body, organs, tissues and cells and the legal and bioethical prerequisites for their use. Students will evaluate the regulation of organ and tissue donation, procurement, transplantation and use, the principle of informed consent, the protection of the rights of the donor and recipient, as well as the importance of the principles of human dignity and the inviolability of the body. |
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Lecture
|
Modality
|
Location
|
Contact hours
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|---|---|---|
|
On site
|
Auditorium
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2
|
Topics
|
Biobanking: a legal framework for human biological samples and associated data
Description
The topic will address the legal and bioethical aspects of the establishment and operation of biobanks, the collection, storage and use of biological samples of human origin for research. Informed consent models, individual rights in relation to biological samples, protection of genetic and health data, secondary use of samples and the role of biobanks in biomedical research will be analysed. |
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Lecture
|
Modality
|
Location
|
Contact hours
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|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Reproductive health: legal aspects of medical fertilization
Description
Students will analyse sexual and reproductive health rights and the legal framework for medical fertilisation. The rights of individuals to access reproductive medical services, the use of donor gametes, informed consent, reproductive autonomy, and the balancing of the rights and interests of the child, the donor, and the prospective parents will be examined. |
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Class/Seminar
|
Modality
|
Location
|
Contact hours
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|---|---|---|
|
On site
|
Auditorium
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2
|
Topics
|
The right to a dignified end of life and palliative care
Description
Students will analyze the importance of the principles of human dignity, autonomy and self-determination at the end of life. The patient's right to palliative care, pain and symptom relief, information and participation in decision-making, as well as the legal and bioethical aspects of the patient's prior expressed will and the involvement of relatives will be discussed. |
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Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Euthanasia and assisted suicide: legal and bioethical challenges
Description
The topic will analyse the concepts of euthanasia and assisted suicide, their distinction from the termination of treatment and palliative care, as well as the regulatory models of various countries. Students will evaluate the interaction between the right to life, personal autonomy, human dignity, the positive obligations of the state and the professional responsibility of medical practitioners, also analysing the case law of the European Court of Human Rights. |
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Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
The legal status of the embryo and surrogacy
Description
The topic will analyse the legal and bioethical status of the human embryo, the creation, storage, use and destruction of embryos in the context of medical fertilisation and biomedical research. The legal models of surrogacy, the determination of the origin of the child, the rights and obligations of the persons involved, as well as the challenges of surrogacy across borders in terms of human rights and private international law will be discussed. |
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Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Withholding and withdrawal of life-sustaining treatment
Description
The topic will analyze the legal and bioethical aspects of not starting and stopping life-sustaining therapy. Students will evaluate patient autonomy, refusal of treatment, principles of medical usefulness and proportionality, professional responsibility of medical practitioners, decision-making in situations where the patient is unable to express his or her will, as well as the distinction between these decisions and euthanasia and assisted suicide. |
|
Biohacking: legal and bioethical aspects
Description
Students will analyse the concept of biohacking and the modification of human biological capabilities outside the traditional framework of medical treatment and scientific research. Legal and bioethical aspects of self-experimentation, implantable technologies, genetic modification, and other biohacking practices will be examined, with a focus on personal autonomy, bodily integrity, safety, informed consent, and legal liability. |
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Transhumanism: The legal limits of human transformation
Description
Students will analyse the idea of transhumanism and the use of biomedicine and technology to transform and expand human physical, cognitive and biological capacities. The issues of human dignity, identity, autonomy, equality and discrimination will be evaluated, as well as the challenges of the legal system in determining the permissible limits of human and technology integration. |
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Biomedical challenges of the future: digital twins and precision medicine
Description
Students will be introduced to the latest developments in biomedicine, with a focus on digital twins and precision or personalized medicine. The issues raised by these technologies regarding the use of health and genetic data, informed consent, algorithmic decision-making, risks of discrimination, professional liability, and the protection of patients' rights will be analyzed. |
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Health data in the digital age: the European Health Data Space (EHDS) and secondary use of data
Description
The topic will analyze the use of health and genetic data in the digital environment, with a focus on the European Health Data Space (EHDS). Students will evaluate the legal framework for primary and secondary use of health data, the use of data in scientific research, innovation and policy-making, as well as issues of personal privacy, data protection and control over their health data. |
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Video Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Artificial intelligence and innovation in medicine
Description
The topic will analyze the use of artificial intelligence and other innovative technologies in medicine and biomedicine. Students will evaluate the use of artificial intelligence in diagnostics, treatment decision-making, and research, addressing issues of algorithmic bias, transparency, human oversight, informed consent, data protection, and legal liability. |
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Human body and biomaterials: transplantation of organs and use of tissues
Description
The topic will analyze the legal status of the human body, organs, tissues and cells and the legal and bioethical prerequisites for their use. Students will evaluate the regulation of organ and tissue donation, procurement, transplantation and use, the principle of informed consent, the protection of the rights of the donor and recipient, as well as the importance of the principles of human dignity and the inviolability of the body. |
|
Biobanking: a legal framework for human biological samples and associated data
Description
The topic will address the legal and bioethical aspects of the establishment and operation of biobanks, the collection, storage and use of biological samples of human origin for research. Informed consent models, individual rights in relation to biological samples, protection of genetic and health data, secondary use of samples and the role of biobanks in biomedical research will be analysed. |
|
Reproductive health: legal aspects of medical fertilization
Description
Students will analyse sexual and reproductive health rights and the legal framework for medical fertilisation. The rights of individuals to access reproductive medical services, the use of donor gametes, informed consent, reproductive autonomy, and the balancing of the rights and interests of the child, the donor, and the prospective parents will be examined. |
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
The legal status of the embryo and surrogacy
Description
The topic will analyse the legal and bioethical status of the human embryo, the creation, storage, use and destruction of embryos in the context of medical fertilisation and biomedical research. The legal models of surrogacy, the determination of the origin of the child, the rights and obligations of the persons involved, as well as the challenges of surrogacy across borders in terms of human rights and private international law will be discussed. |
|
The right to a dignified end of life and palliative care
Description
Students will analyze the importance of the principles of human dignity, autonomy and self-determination at the end of life. The patient's right to palliative care, pain and symptom relief, information and participation in decision-making, as well as the legal and bioethical aspects of the patient's prior expressed will and the involvement of relatives will be discussed. |
|
Euthanasia and assisted suicide: legal and bioethical challenges
Description
The topic will analyse the concepts of euthanasia and assisted suicide, their distinction from the termination of treatment and palliative care, as well as the regulatory models of various countries. Students will evaluate the interaction between the right to life, personal autonomy, human dignity, the positive obligations of the state and the professional responsibility of medical practitioners, also analysing the case law of the European Court of Human Rights. |
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Euthanasia and assisted suicide: legal and bioethical challenges
Description
The topic will analyse the concepts of euthanasia and assisted suicide, their distinction from the termination of treatment and palliative care, as well as the regulatory models of various countries. Students will evaluate the interaction between the right to life, personal autonomy, human dignity, the positive obligations of the state and the professional responsibility of medical practitioners, also analysing the case law of the European Court of Human Rights. |
|
Withholding and withdrawal of life-sustaining treatment
Description
The topic will analyze the legal and bioethical aspects of not starting and stopping life-sustaining therapy. Students will evaluate patient autonomy, refusal of treatment, principles of medical usefulness and proportionality, professional responsibility of medical practitioners, decision-making in situations where the patient is unable to express his or her will, as well as the distinction between these decisions and euthanasia and assisted suicide. |
|
Biohacking: legal and bioethical aspects
Description
Students will analyse the concept of biohacking and the modification of human biological capabilities outside the traditional framework of medical treatment and scientific research. Legal and bioethical aspects of self-experimentation, implantable technologies, genetic modification, and other biohacking practices will be examined, with a focus on personal autonomy, bodily integrity, safety, informed consent, and legal liability. |
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Withholding and withdrawal of life-sustaining treatment
Description
The topic will analyze the legal and bioethical aspects of not starting and stopping life-sustaining therapy. Students will evaluate patient autonomy, refusal of treatment, principles of medical usefulness and proportionality, professional responsibility of medical practitioners, decision-making in situations where the patient is unable to express his or her will, as well as the distinction between these decisions and euthanasia and assisted suicide. |
|
Biohacking: legal and bioethical aspects
Description
Students will analyse the concept of biohacking and the modification of human biological capabilities outside the traditional framework of medical treatment and scientific research. Legal and bioethical aspects of self-experimentation, implantable technologies, genetic modification, and other biohacking practices will be examined, with a focus on personal autonomy, bodily integrity, safety, informed consent, and legal liability. |
|
Transhumanism: The legal limits of human transformation
Description
Students will analyse the idea of transhumanism and the use of biomedicine and technology to transform and expand human physical, cognitive and biological capacities. The issues of human dignity, identity, autonomy, equality and discrimination will be evaluated, as well as the challenges of the legal system in determining the permissible limits of human and technology integration. |
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Biomedical challenges of the future: digital twins and precision medicine
Description
Students will be introduced to the latest developments in biomedicine, with a focus on digital twins and precision or personalized medicine. The issues raised by these technologies regarding the use of health and genetic data, informed consent, algorithmic decision-making, risks of discrimination, professional liability, and the protection of patients' rights will be analyzed. |
|
Health data in the digital age: the European Health Data Space (EHDS) and secondary use of data
Description
The topic will analyze the use of health and genetic data in the digital environment, with a focus on the European Health Data Space (EHDS). Students will evaluate the legal framework for primary and secondary use of health data, the use of data in scientific research, innovation and policy-making, as well as issues of personal privacy, data protection and control over their health data. |
|
Artificial intelligence and innovation in medicine
Description
The topic will analyze the use of artificial intelligence and other innovative technologies in medicine and biomedicine. Students will evaluate the use of artificial intelligence in diagnostics, treatment decision-making, and research, addressing issues of algorithmic bias, transparency, human oversight, informed consent, data protection, and legal liability. |
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Biomedical challenges of the future: digital twins and precision medicine
Description
Students will be introduced to the latest developments in biomedicine, with a focus on digital twins and precision or personalized medicine. The issues raised by these technologies regarding the use of health and genetic data, informed consent, algorithmic decision-making, risks of discrimination, professional liability, and the protection of patients' rights will be analyzed. |
|
Health data in the digital age: the European Health Data Space (EHDS) and secondary use of data
Description
The topic will analyze the use of health and genetic data in the digital environment, with a focus on the European Health Data Space (EHDS). Students will evaluate the legal framework for primary and secondary use of health data, the use of data in scientific research, innovation and policy-making, as well as issues of personal privacy, data protection and control over their health data. |
|
Artificial intelligence and innovation in medicine
Description
The topic will analyze the use of artificial intelligence and other innovative technologies in medicine and biomedicine. Students will evaluate the use of artificial intelligence in diagnostics, treatment decision-making, and research, addressing issues of algorithmic bias, transparency, human oversight, informed consent, data protection, and legal liability. |
Bibliography
Required Reading
Altman, M. C., & Schwan, D. (Eds.). (2025). Ethics and medical technology: Essays on artificial intelligence, enhancement, privacy, and justice. Springer.Suitable for English stream
Casarosa, F., Gennari, F., & Rossi, A. (Eds.). (2025). Enabling and safeguarding personalized medicine. Springer.Suitable for English stream
Colcelli, V., Cippitani, R., Brochhausen-Delius, C., & Arnold, R. (Eds.). (2023). GDPR requirements for biobanking activities across Europe. Springer.Suitable for English stream
Crouch, M. (2025). Medical genetics and law: An international perspective (2nd ed.). Springer.Suitable for English stream
Draghici, C. (2024). Procreative rights in international law: Insights from the European Court of Human Rights. Cambridge University PressSuitable for English stream
Ferrara, A. (2025). Bioethical reflections on the border between life and death. Springer.Suitable for English stream
Hayenhjelm, M., & Nordlund, C. (2025). The risks and ethics of human gene editing: A philosophical guide to the arguments. Springer VS.Suitable for English stream
Laing, J. M., & McHale, J. V. (Eds.). (2025). Principles of medical law (5th ed.). Oxford University Press.Suitable for English stream
Laurie, G., Dove, E., Ganguli-Mitra, A., McMillan, C., Postan, E., Sethi, N., & Sorbie, A. (Eds.). (2021). The Cambridge handbook of health research regulation. Cambridge University Press.Suitable for English stream
European Parliament & Council of the European Union. (2025). Regulation (EU) 2025/327 of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847. Official Journal of the European Union, L, 2025/327.Suitable for English stream
Additional Reading
Council of Europe. (1950). Convention for the protection of human rights and fundamental freedoms (ETS No. 5).Suitable for English stream
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 (ETS No. 164).Suitable for English stream
European Parliament & Council of the European Union. (2016). Regulation (EU) 2016/679 of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data and repealing Directive 95/46/EC. Official Journal of the European Union, L 119, 1–88.Suitable for English stream
European Parliament & Council of the European Union. (2024). Regulation (EU) 2024/1689 of 13 June 2024 laying down harmonised rules on artificial intelligence and amending certain Union legislative acts. Official Journal of the European Union, L, 2024/1689.Suitable for English stream
Other Information Sources
Ārstniecības likums. (1997). Latvijas Vēstnesis, 167/168. Spēkā esošā konsolidētā redakcija.Suitable for English stream
Biobanku likums. (2026). Latvijas Vēstnesis, 99. Spēkā esošā redakcija.Suitable for English stream
Pacientu tiesību likums. (2009). Latvijas Vēstnesis, 205. Spēkā esošā konsolidētā redakcija.Suitable for English stream
Par miruša cilvēka ķermeņa aizsardzību un cilvēka audu un orgānu izmantošanu medicīnā. (1992). Latvijas Republikas Augstākās Padomes un Valdības Ziņotājs, 1/2. Spēkā esošā konsolidētā redakcija.Suitable for English stream