SNITEM & Philips France vs. Health Minister: the ECJ defines the conditions under which software for assistance to the medical prescription can be qualified medical device within the meaning of the Directive.
This second article in the 4-part series looks at the use of software in medical devices in non-clinical settings, particularly the home environment. It addresses software’s role in the home healthcare trend, explains the software-related risks that arise from home-use products, and discusses what manufacturers can do to make these products safer.
As standalone software becomes increasingly sophisticated, a number of regulatory bodies have begun to draft separate guidelines to ensure quality control, expedite product approval, and improve patient access to new technologies.
By adhering to FDA recommendations and leveraging the expertise of proven cyber testing methods, manufacturers can tackle known cybersecurity issues today while also attempting to anticipate concerns that may lie ahead.
How software is changing the legal landscape for medical device manufacturers.
The corrective action is intended to reduce the risk of patient harm as a result of cybersecurity vulnerabilities in the products.
High-resolution options can enhance patient care and safety, and surgical efficiency.
According to the Advocate General’s interpretation of the Directive and related soft law (i.e., MEDEV guidelines), software allowing the prescriber to detect contraindications, drug interactions and excessive doses shall qualify as a medical device.
When a software patch or device update cannot remedy a cyber threat, sometimes a recall is necessary.
The initiative also focuses on how devices will be regulated in the post-market world.