LLTS009 Health Science and Technology (3 op)

Content

• Using current information to evaluate future trends in wellness and health technology

• Legislation and regulation of technologies and services in sports, health and medicine

• European medical device database (EUDAMED)

• Scientific basis; ethics and risk management

• Scientific basis; validity and reliability

• Conformity assessment procedures

Completing methods

• Lectures and seminars 20 hours

• Independent group work and its presentation (may be done individually, in pairs or in larger groups based on number of students at course)

• Literature and book reading

• Active participation in the lectures and group work and writing assignments, examination based on set literature or written report of group work and its oral presentation. 

Assessment details

Assessment details

• Participation, group work or final exam/written report
  Attendance to course lectures/seminars 90% in order to pass the course. Note! Oral seminar presentations cannot be substituted by other work. 

On successful completion of this course, student is able to

• find the basic information on health/wellness technology market and trends

• differentiate medical device from other types of health technologies

• describe how medical, health and wellness technologies or services are regulated

• build link between scientific knowledge and research and development (R&D) products

• evaluate health and wellness technologies or services -associated safety, risk management and ethics -related issues

• recognize the general safety and performance requirements for medical device (MD) and in-vitro diagnostic (IVD) products

Spring

Dhillon, B.S. 2000. Medical device reliability and associated areas. Boca Raton: CRC Press. (240 p.) Chapters included in the exam will be told at the lectures.

Onel, S. & Becker, K.M. (eds.) 2014. Medical devices law and regulation answer book 2014. New York, NY: Practising Law Institute. (1000 p.) 

Study materials:

Bankert, E.A. & Amdur, R.J. 2005. Institutional review board: management and function. 2nd edition. Boston, MA: Jones & Bartlett. (530 p.)

Simmers, L., Simmers-Nartker, K., Simmers-Kobelak, S. 2008. Introduction to health science technology. 2nd edition. Clifton Park, NY: Delmar Cengage Learning. (656 s.)

Wassertheil-Smoller, S. 2004. Biostatistics and epidemiology: a primer for health and biomedical professionals. 3. painos. New York, NY:Springer. (243 s.)