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Computer screens in hospital

Standards, interoperability and regulation in health informatics

Tampere University

Extent

5 ECTS

Course dates

9.1.2023-5.3.2023

Application period

15.6.2022-20.12.2022

Fees

1400,00 € + VAT 24 % (Price incl. VAT 1 736 €)

Faculty or school

Language of instruction

English

Study fields

Management, Administration and Economics
Technology and Natural Sciences
Health and Welfare
Data Processing and Information Technology

Organising unit

Tree – Continuing Education

Mode of study

Multi-modal teaching
Online studies

Study level

Other studies

Extensive information package on regulations, standards and interoperability in health informatics and software development

An increasing variety of information systems and software are being developed for healthcare needs. Because many of them process patient data or are directly related to, for example, diagnosis, they are strictly regulated by the authorities. When developing such products, you need to know and understand the regulations and standards in force.

This course delves into those regulations, requirements, and standards. Additionally, system's interoperability, security and data protection are the central themes of the course. The course also introduces the quality and risk management systems required in the software production in the field and cyber security requirements.

Target group

The course is targeted to those who are working or willing to work in health software development companies or health information system management roles in health delivery organizations. The course gives essential knowledge also for health technology start-ups and anyone who wants to update his or her knowledge about standards, interoperability, and regulations in health informatics.

Basic knowledge of healthcare information systems, software production and communication protocols are an advantage in the course.


This course is part of Health technology solutions – product development and commercialization (programme). Get acquainted with the programme and other courses included in it.

The programme offers a formal additional education for a “Person responsible for regulatory compliance” required by the new EU regulations in Medical Devices Regulation (MDR) and In-vitro Diagnostics Regulation (IVDR).