Continuing Education

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

Faculty of Medicine and Health Technology

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

To application form

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).

Completion of studies

The course covers the following topics:

Health informatics regulations, particularly for health software production: key international directives, national regulation, self-regulation.
Security, privacy, and data protection. Principles, regulation and guidelines for application in health informatics.
Standards and interoperability in health informatics. Key standards: HL7, CDA, IHE, etc.
Health information systems conformance assessment.

After completing this course, you:

can define what data security, privacy and safety
know the central regulations related to health information systems, privacy, and security of health data, and know how they need to be taken into account in health information system development
know general health informatics standards and interoperability approaches and can describe how they are applied in practice
can apply the most important standards which are widely used in Finland in health information systems in software development
can assess whether a health information system is implemented according to regulations and interoperability principles

Teaching

The course includes an introductory live lecture, a series of video lectures and assignments.

Assignments are done in joint exercise sessions in Tampere at Hervanta campus, typically in small groups, but it is possible to do them remotely as individual exercises as well. Each particant also prepares a personal mind map of the course as a learning assignment.

The course can be completed entirely online.

The teacher of the course is Alpo Värri.

Alpo Värri has been involved in the standardization of healthcare information technology since the 1990s.

He chairs the WG2 Technology and applications working group TC251 Health Informatics of the European Committee for Standardization CEN Technical Committee. In addition, he has participated in the development of several standards in the ISO / TC215 and IEEE 11073 standardization committees.

Cancellation terms

Application for the training becomes binding after the last application date.

For cancellation made after the end of the application period, 50% of the participation fee will be charged.
If the cancellation takes place 1-14 days before the start of the training, the entire price of the training will be charged.

In the event of an obstacle, the place of training can be handed over to a colleague. In trainings with separate selection criteria, a place cannot be handed over to another.

To application form