Software

ARTICLES

Cybersecurity Bill Draws Support From Stakeholders

A recently introduced cybersecurity bill for medical devices is attracting some support — at least from the medical community. Read More

MDISS Unveils First of Many Device Security Testing Labs

The Medical Device Innovation, Safety and Security Consortium has launched the first of its many device security testing labs planned for 2017 as part of its… Read More

Devicemakers Call Nation-States Top Cybersecurity Threat

Devicemakers view government-sponsored hackers as the top cybersecurity threat, according to a new survey from KPMG. Read More

Senate Bill Aims to Block Hacks of Medical Devices

Medical devices would have to be better protected against hackers under a cybersecurity bill introduced Aug. 1 by U.S. Sen. Richard Blumenthal (D-Conn.). Read More

Most Users Accept Sharing Data From Networked Medical Devices

More than three out of four consumers approve the immediate transmission to their doctors via the Internet of significant changes in medical conditions recorded by networked pacemakers, blood-sugar sensors or other devices, according to a 2017 survey by Unisys. Read More

FDA Launches Device Software Pre-certification Pilot

The FDA’s new pilot program for pre-certifying software for digital medical devices is up and running — and companies can apply to take part in the program on August 1. Read More

HPRA Issues Guidance on Device Standalone Software

Ireland’s Health Products Regulatory Authority released new guidance on medical device standalone software. Read More

Cardiac Devices Pose Cybersecurity Challenges, Study Finds

A new study of the four biggest makers of pacemaker systems found thousands of software vulnerabilities, highlighting an industry-wide problem with software security updates. Read More

Australia Follows FDA and IMDRF Lead in Regulating Software

Australia’s Therapeutic Goods Administration will likely follow the FDA’s lead and the International Medical Device Regulators Forum’s model for regulating … Read More

FDA Advances Plans for a Digital Health Unit

The FDA is moving ahead with the creation of a Digital Health Unit to address software validation for devices and other issues relating to health information technology. Read More