Healthcare & Health IT

Countries such as Germany, Austria, Switzerland, and the USA spend over ten percent of their gross national product on their healthcare systems. However, the systems differ significantly in terms of their efficiency and effectiveness. This is due to both, the legislation, and the varying degrees of digitalization.

1. Articles on healthcare

In this category, you will find articles on the following topics:

• Players in the healthcare sector
  • Federal Institute for Drugs and Medical Devices
  • Hospitals and clinics
• Market trends and health policy and general medical topics

2. Articles on health IT

• Medical software and standalone software, such as clinical information systems and digital health applications
• Data protection and IT security in the healthcare sector
• Interoperability of medical devices and information systems
• Telematic infrastructure
• Medical cloud and cloud computing in healthcare

3. Articles on the regulatory context

a) Product development

If you are faced with the task of developing a device for the healthcare market, then take note of this information:

• Introduction to the regulatory system with the starter kit
• Qualification and classification of software
• Overview of all regulatory requirements
• EU Data Act

b) Use and operation of medical devices

These articles are relevant for health institutions:

• Impact of MDR and IVDR on health institutions such as hospitals
• Caution with in-house production of medical devices
• Laboratories: In-house IVD (Lab Developed Tests)
• Medical Device Operator Ordinance