Directives, Regulations and Requirements for Digital Health Products


Content, progress and pedagogy of the module

Directives, regulations and requirements for digital health products, with the aim of providing students with insight and familiarity with the new requirements, regulations, and directives within digital health. Through this course element, students will be able to contribute to the technically required transformation towards the digital health sector. This is achieved by teaching students how to qualify health IT as medical devices. Furthermore, they learn professionally to engage in and contribute to discussions and knowledge sharing about regulations and directives regarding the use of health IT solutions and special considerations when these solutions are based on artificial intelligence. 

Learning objectives


  • Can account and describe the purpose of standards, regulatory conditions, documents, and organizations relevant for digital health products. 

  • Can account for phases in regulatory life cycle of digital health products internationally and in Europe, including organizational, practical, timing requirements and evidence related to quality control. 

  • Can describe the standardization process and can account for the relevant standardization organizations. 

  • Can describe the special considerations for digital health products when based on artificial intelligence.


  • Can prepare a clinical evaluation plan, a risk management plan, and identify challenges in relation to regulatory approval of a digital health product. 

  • Can establish the necessary documentation for approval of digital health products. 

  • Can identify strategies for handling protection of personal data, cybersecurity, and requirements for traceability. 

  • Can identify risk classification for a digital health product and the associated classification requirements.


  • Can identify relevant standards for a given digital health product

Type of instruction

The teaching format is blended learning based on self-study of both written material and video clips, discussion in study groups, online seminars, case-studies and workshops, where students will train short presentations of their work in groups.  



Name of examDirectives, Regulations and Requirements for Digital Health Products
Type of exam
Written or oral exam
Permitted aidsSee semester description
Assessment7-point grading scale
Type of gradingInternal examination
Criteria of assessmentThe criteria of assessment are stated in the Examination Policies and Procedures

Facts about the module

Danish titleForordninger, regulativer og krav til brug af digitale sundhedsteknologiske produkter
Module codeSOTDH24M1_1
Module typeCourse
Duration1 semester
Language of instructionEnglish
Location of the lectureCampus Aalborg
Responsible for the module


Education ownerMaster of Digital Health
Study BoardStudy Board of Health and Technology
DepartmentDepartment of Health Science and Technology
FacultyThe Faculty of Medicine