The digitisation of the medical sector brings with it countless opportunities to improve healthcare, specifically the care available to patients and the data available to their practitioners and care providers. At the same time, there are risks inherent in digitisation that need to be addressed, especially in the case of connected medical devices.
Despite the strict requirements for protection of data confidentiality, integrity and availability, it’s easy to get overwhelmed by the regulations, the numerous standards and guidance documents available and the differing approaches, leaving you unsure where to start and how to demonstrate effective compliance.
Cyber security is vital for patient safety, for data security and for data integrity; it’s important that you understand the drivers, regulation and what you can do to ensure your devices are safe and secure.
The Medical Device Coordination Group (MDCG) is a coordination group established under Article 103 of the MDR. Its key functions include contributing to the development of guidance to ensure effective and harmonized implementation of the EU medical device rules. I will be explaining key aspects of the MDCG 2019/16 – “Guidance on Cybersecurity for medical devices” giving an overview and explaining why it is critically important.
WHO SHOULD ATTEND
Anyone involved in the product development of connected medical devices, anyone responsible for quality, regulatory affairs and MDR / IVDR compliance and those involved in digital health.
KEY LEARNING / TAKEWAY
How MDCG 2019/16 can help you develop more secure connected medical devices.