| CODE | MCT5013 | ||||||||||||||||
| TITLE | Ethics Law and Compliance in Digital Health | ||||||||||||||||
| UM LEVEL | 05 - Postgraduate Modular Diploma or Degree Course | ||||||||||||||||
| MQF LEVEL | 7 | ||||||||||||||||
| ECTS CREDITS | 5 | ||||||||||||||||
| DEPARTMENT | Media, Communications & Technology Law | ||||||||||||||||
| DESCRIPTION | The introduction of digital health promises benefits in the way healthcare is provided by healthcare givers and accessed by patients. This introduction of digital health however also brings dilemmas from an ethical and legal perspective on, for example, access to healthcare, processing of personal data, application safety, use of AI and robots etc. The design and implementation of digital health must take into account ethical concerns and applicable legal frameworks. Translating ethical norms and legal rules into features of design and implementation may prove difficult. Study-unit Aims: This unit aims at: - Introducing and discussing ethical concerns in digital health; - Mapping and discussing five sets of legal and regulatory frameworks; o Data protection and medical confidentiality; o Regulation of medical devices; o Product safety and security; o Liability and responsibility; o Intellectual property protection. - Assisting in identifying methodologies on how to integrate ethical norms and legal rules in the design and implementation of digital health: digital compliance-by-design strategies; - Reflecting on different regulatory approaches to ensure compliance. Learning Outcomes: 1. Knowledge & Understanding By the end of the study-unit the student will be able to: a. Describe and explain ethical norms and legal rules applicable in the context of the design and implementation of digital health; b. Apply the ethical norms and legal rules digital health ought to be compliant with; c. Explore and evaluate compliance-by-design methodologies and strategies. 2. Skills By the end of the study-unit the student will be able to: a. Critically evaluate and interpret ethical theories and legal rules in order to apply them to the design and implementation of digital health; b. Use and adapt legal frameworks in the design and implementation of digital health applications; c. Collaborate in a multidisciplinary online team to understand compliance needs and compliance strategies; d. Take responsibility for initiating, identifying and using new skills and techniques to respect ethical norms and legal rules when designing and implementing digital health applications. Main Text/s and any supplementary readings: Main Texts - Brall C., Schröder-Bäck P., Maeckelberghe E., Ethical aspects of digital health from a justice point of view, European Journal of Public Health, Volume 29, Issue Supplement_3, October 2019, Pages 18–22, https://doi.org/10.1093/eurpub/ckz167 - Cohen, I., Lynch, H., Vayena, E., & Gasser, U. (Eds.). (2018). Big Data, Health Law, and Bioethics. Cambridge: Cambridge University Press. doi:10.1017/9781108147972 - Nebeker, C., Torous, J. & Bartlett Ellis, R.J. Building the case for actionable ethics in digital health research supported by artificial intelligence. BMC Med 17, 137 (2019). https://doi.org/10.1186/s12916-019-1377-7 - Purtova N., Kosta E., Koops BJ. (2015) Laws and Regulations for Digital Health. In: Fricker S., Thümmler C., Gavras A. (eds) Requirements Engineering for Digital Health. Springer, Cham. Supplementary texts: - Aicardi, Christine et al. “Emerging ethical issues regarding digital health data. On the World Medical Association Draft Declaration on Ethical Considerations Regarding Health Databases and Biobanks.” Croatian medical journal vol. 57,2 (2016): 207-13. doi:10.3325/cmj.2016.57.207 - Brost G.S., Hoffmann M. (2015) Identifying Security Requirements and Privacy Concerns in Digital Health Applications. In: Fricker S., Thümmler C., Gavras A. (eds) Requirements Engineering for Digital Health. Springer, Cham - Drosatos, G., Efraimidis, P., Williams, G. and Kaldoudi, E.Towards Privacy by Design in Personal e-Health Systems. DOI: 10.5220/0005821404720477In Proceedings of the 9th International Joint Conference on Biomedical Engineering Systems and Technologies (BIOSTEC 2016) - Volume 5: HEALTHINF, pages 472-477 - Jumelle A.K.L., Ispas I. (2015) Ethical Issues in Digital Health. In: Fricker S., Thümmler C., Gavras A. (eds) Requirements Engineering for Digital Health. Springer, Cham - Vayena E, Haeusermann T, Adjekum A, Blasimme A. Digital health: meeting the ethical and policy challenges. Swiss Med Wkly. 2018;148:w14571. Published 2018 Jan 16. doi:10.4414/smw.2018.14571. |
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| STUDY-UNIT TYPE | Blended Learning | ||||||||||||||||
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| LECTURER/S | Daniel Bianchi Jeanne Pia Mifsud Bonnici (Co-ord.) Mireille-Martine Sant |
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The University makes every effort to ensure that the published Courses Plans, Programmes of Study and Study-Unit information are complete and up-to-date at the time of publication. The University reserves the right to make changes in case errors are detected after publication.
The availability of optional units may be subject to timetabling constraints. Units not attracting a sufficient number of registrations may be withdrawn without notice. It should be noted that all the information in the description above applies to study-units available during the academic year 2024/5. It may be subject to change in subsequent years. |
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