SMIM20002U Digital Health

Volume 2024/2025

Master of Industrial Drug Development (MIND) - elective

The course is preapproved as an elective in the   Master Medicines Regulatory Affairs (MRA) programme. It is also open to single course students who meet the admission criteria.


The course is offered under the Copenhagen Summer University (CSU).



The scientific literature and popular media frequently comment on how digital health offers new and improved ways of delivering health care. Digital solutions include a wide range of health care products and services ranging from AI-based clinical support to telemedicine and telehealth. Digital health technology includes simple apps and scheduling tools as well as digital interventions that completely replace pharmaceuticals or other traditional health care interventions as in the case of insomnia treatment. Despite the promises and prospects of digital solutions there are many challenges and problems to be solved in this new digital health era. 

Digital health technology introduces new and innovative solutions for health care at the same time optimizing patient outcomes. It provides the possibility for patients to gain more control over their treatment and become more sovereign in handling their own unique health care situation. Digital tools can change the patient pathways, the choice of interventions and the relationship between the actors in a treatment situation.

Patients now play a central role in their own health care due to improvements in self-monitoring and self-care made possible by real world data and new digital solutions. This situation requires new methods for measuring the value of digital solutions for regulators, health care providers, patients and payers.

The course will address the following:

  • Introduction to Digital Health Care
  • Digital health practices – examples from the real world
  • Stakeholders, new players and new business models
  • Possibilities for collaboration between Big Tech, decision makers, practitioners and patients
  • Impact on patient relevant outcomes
  • Ethical concerns and transparency issues
  • The regulatory environment for digital tools
  • The complexities of reimbursement in digital health 
  • Big data and what it means for the future of healthcare
  • Advanced drug delivery systems
Learning Outcome

Upon completion of the course, participants will have gained the following knowledge, skills and competencies:


  • Acquire a basic vocabulary and understanding of digital health solutions and issues 
  • Understand the ethical concerns and transparency issues of digital health
  • Understand the key steps in developing and implementing digital health solutions



  • Identify the key stakeholders, their interests and motivations
  • Discuss and evaluate rationales for and consequences of digital health solutions
  • Identify, evaluate and discuss ethical concerns



  • Critically reflect upon digital health proposals and practices
  • Communicate specific issues and proposals for digital health with other specialists and stakeholders
  • Collaborate within a multi-disciplinary digital health project team


The compulsory syllabus comprises a collection of scientific articles, review papers and case studies corresponding to approximately 500 pages (extra 200 pages self-selected literature for the optional exam).

Applicants must meet the following criteria:
• A bachelor's degree, a professional bachelor’s degree, a diploma degree, a master’s degree or equivalent within chemistry, biochemistry, pharmacy, medicine, biomedicine, human biology, molecular biology, veterinary sciences, health sciences, nursing, engineering or equivalent.
• At least two years of relevant work experience related to development of medicines
• Proficiency in English
Applicants must meet the following criteria:
• A relevant bachelor degree or equivalent
• A minimum of 2 years of relevant job experience
• Proficiency in English
This is an intensive 5-day course. Teaching methods consist of a combination of lectures, group discussions, case studies, presentations, exercises and panel discussions.
  • Category
  • Hours
  • Class Instruction
  • 40
  • Preparation
  • 24
  • Exam
  • 20
  • Total
  • 84
Continuous feedback during the course of the semester
Type of assessment
Written assignment
Type of assessment details
A written assignment. Individual written assignment based on a relevant set of questions provided by the course managers and based on an extended literature list.
All aids allowed
Marking scale
passed/not passed
Censorship form
No external censorship
Exam period

Will be announced on the MIND and MRA program's webpage


The exam form for the reexam is the same as the ordinary exam. See dates in the exam schedule on the MIND and MRA program's webpage

Criteria for exam assesment

To achieve the grade passed, the participant shall (in an adequate level) be able to demonstrate:


  • Describe and discuss the current and future developments for digital health care
  • Identify the regulatory challenges of digital health products and services
  • Discuss the pros and cons of home-based digital health solutions


Skills for:

  • Describing, assessing and discussing the various perspectives and potential conflicts of key stakeholders associated with digital health
  • Discussing and arguing for ethical guidelines regarding the use of patient data


Compentencies to:

  • As a professional, be able to participate in multidisciplinary teams and contribute to digital health projects from a critical and constructive perspective