This course delves into the requirements, standards and regulations for information systems and software used in healthcare. Systems 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.

Join this course to deepen your skills!

This course is part of Health technology solutions – product development and commerzialization study module. Get acquainted with the study module and other courses included in it. The study module 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).

Apply for the course

Teaching begins on the 11th of January 2021. Send your application by the 3rd of January!
A maximum of 30 persons will be accepted.

To application form

Kuvassa silmälasipäinen mies katsoo kameraan.

Here are all the courses and the study module mentioned previously

Health technology solutions – product development and commercialization

Study module - non degree

Content owner
Tampere University

Course dates: 01.09.2020 - 30.06.2021 Type: Continuing Education Extent: 15 ECTS Duration: 10 months City: Tampere
Introduction to quality and regulation for medical product development

Study module - non degree

Content owner
Tampere University

Course dates: 01.09.2020 - 18.10.2020 Type: Continuing Education Extent: 5 ECTS Duration: 3 months City: Tampere
Regulatory requirements for design and manufacture of medical devices

Study module - non degree

Content owner
Tampere University

Type: Continuing Education Extent: 5 ECTS Duration: 3 months City: Online course, Tampere
Standards, interoperability and regulation in health informatics

Study module - non degree

Content owner
Tampere University

Course dates: 11.01.2021 - 07.03.2021 Type: Continuing Education Extent: 5 ECTS Duration: 3 months City: Online course, Tampere
Product development of biomedical devices

Study module - non degree

Content owner
Tampere University

Type: Continuing Education Extent: 5 ECTS Duration: 6 months City: Tampere

Duration

3 months

Extent

5 ECTS

Course dates

11.1.-7.3.2021

Application period

1/6/2020 - 3/1/2021

Application by

3/1/2021

Fees

1 400 € + VAT 24 % (Price incl. VAT 1 736 €)

City

Online course

Tampere

Faculty or School

Faculty of Medicine and Health Technology

Language of instruction

English

Study fields

Data Processing and Information Technology

Health and Welfare

Management, Administration and Economics

Technology and Natural Sciences

Organising unit

Tree – Continuous Education

Mode of study

Multi-modal teaching

Study level

Other studies

Standards, interoperability and regulation in health informatics

Contents

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 and privacy and security of health data and knows 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

Target group

Teaching

The course has 8 lectures that are or will be recorded. There are also 6 exercises, of which at least 4 need to be completed to pass the course.

Exercises are organized in Tampere, but it is possible to do them online as well. Student also does a personal mind map of the course. There is an exam at the end of course.

The course can be completed entirely online.

The teacher of the course is Alpo Värri.

Teacher(s)

Contact

Teemu Rauhala

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. The training contact person must be informed of the change in writing or by e-mail.
In trainings with separate selection criteria a place can not be handed over to another.

The cancellation must be made in writing or by e-mail to the contact person for the training.

Register

Standards, interoperability and regulation in health informatics

Apply for the course

Here are all the courses and the study module mentioned previously

Health technology solutions – product development and commercialization

Introduction to quality and regulation for medical product development

Regulatory requirements for design and manufacture of medical devices