New cybersecurity standard 

The requirements of the cybersecurity standard for medical devices, which was published a short time ago, surpasses what regulators are now looking for from medical device manufacturers. 

The new standard has been adopted by the International Electrotechnical Commission (IEC) and the  International Organisation for standards (ISO). IEC 81001-5-1 requires  developers of medical device software to include certain lifecycle cybersecurity standards that could be onerous for non-device health software manufacturer. It could mean health care software manufacturers would have to fulfil requirements like those concerning Software of Unknown Provenance (SOUP), software architectural design, safety risk management, problem resolution, and documented static reviews of requirements, architecture and design.

Although the standard is not yet recommended by regulatory bodies, authorities worldwide may think about implementing it in the future. 

Source: Medtech Insight (an Informa product)

Accompanying this subject we recommend the following content on our website