Medical Software Security, Privacy and Solution Certification

Data is displayed for academic year: 2024./2025.

Lecturers

Assoc. Prof.
Predrag Pale

Course Description

The course includes analysis of key concepts, parameters and elements associated with the security and privacy of medical data, in context of software solutions and EHR applications on global scale. It addresses aspects of GDPR and HIPAA acts, and their impacts on healthcare information systems implementations. It addresses the profiles of security when dealing with patient EHR, and includes the technologies such as IHE, SMART on FHIR, CDA authorization properties and similar. Finally, it includes the analysis of regulatory and certification programs, such as MDD, IHE and PHCA, including categories of medical devices in SW implementations

Study Programmes

Learning Outcomes

  1. Describe risk elements when it comes to misusage of medical information
  2. Identify the legal aspects of electronic data records (security, integrity, authenticity, non-repudiation)
  3. Explain the importance of GDPR in medical informatics
  4. Describe most prominent certification and regulatory initiatives (IHE, MDD, PCHA)
  5. Give example of using and implementing IHE ITI profile in definition of rights to access patient data
  6. Apply the requirements for biomedical data security in practice

Forms of Teaching

Lectures

Seminars and workshops

Week by Week Schedule

  1. Lectures: Analysis of key concepts, parameters and elements associated with the security and privacy of medical data, in context of software solutions and EHR applications on global scale
  2. Lectures: Data privacy and security provisions – GDRP, HIPAA
  3. Lectures: Certification and regulatory aspects – MDD
  4. Lectures: Technologies in areas of healthcare security – EHR configuration, security, data privacy
  5. Lectures: Technologies in areas of healthcare security – EHR configuration, security, data privacy, CDA
  6. Lectures: Technologies in areas of healthcare security – SMART on FHIR, REST API
  7. Lectures: Technologies in areas of healthcare security – SMART on FHIR, REST API
  8. Lectures: Midterm exam
  9. Lectures: Profiles, certification and regulatory aspects – IHE ATNA, BPPC, XUA; Continua, secondary usage of data
  10. Lectures: Profiles, certification and regulatory aspects – IHE ATNA, BPPC, XUA; Continua, secondary usage of data
  11. Lectures: EHR architectures in context of security requirements
  12. Lectures: Quality frameworks of mHealth apps
  13. Lectures: Blockchain and it's application in healthcare (in context of security)
  14. Lectures: Seminar presentations and discussions
  15. Lectures: Final exam

Literature

(.), Tim Benson, Grahame Grieve (2021.), Princpiples of Health Interoperability 4th Edition, Springer Nature Switzerland,
(.), Miroslav Končar (2010.), Interoperability of Health Systems. HL7 Compliant Implementation Model: Framework for Localizing Health Care IT Solutions Based on HL7 Standard, LAP Lambert Academic Publishing,
(.), J. Kern, M. Petrovečki (Ur.) (2009.), Medicinska informatika, Medicinska naklada, Zagreb,
(.), H. Van Bemmel, M.A. Musen (1997.), Handbook of Medical Informatics, Springer Verlag,

For students

General

ID 261448
  Winter semester
5 ECTS
L3 English Level
L1 e-Learning