Cybersecurity

As the Biden administration works to draft guidance for industry around COVID-19 vaccine passports -- digital health passes that can provide proof of vaccination and be used by businesses to screen people for vaccination status -- digital health groups say they want the federal government to play an even bigger role in in the development process, specifically by creating a unifying set of standards for industry, providing funding for developers, and allowing some apps to link up with federal agencies so they can notify users of new and updated federal guidance.

As the Biden administration pushes for more over-the-counter and at-home COVID-19 tests, health technology and privacy experts say they’re worried about the lack of privacy regulations in the space.

Melissa Hathaway, a cybersecurity advisor to Democratic and Republican presidents, is urging the incoming Biden-Harris team to lead a pivot from the successful, CISA-led election security effort to securing the healthcare sector against an onslaught of cyber attacks related to the COVID-19 pandemic.

A group of Senate Republicans led by Commerce Chairman Roger Wicker (R-MS) has introduced legislation to give consumers choices and control over how their personal health, device, geolocation and proximity data can be collected.

Cyber policy pros are urging operators of industrial control systems and other critical infrastructure to be particularly alert to cyber threats following the U.S. attack that killed Iran's top general, amid intense discussions on whether the right cyber policy tools are in place for a potentially unprecedented confrontation in cyberspace.

FDA notified device manufacturers, providers and patients on Tuesday (Oct. 1) that connected medical devices and health care networks that use certain communication software are vulnerable to potential cybersecurity attacks.

The Healthcare and Public Health Sector Coordinating Council has issued a list of information-sharing organizations as a resource for assisting hospitals, physicians, drug and device makers, and others within the healthcare industry to defend against cybersecurity threats, with additional guidance expected to come.

FDA on Tuesday (July 2) announced that it will meet with patients to come up ideas for how FDA, the medical device industry and health care providers should tell patients and the public about cybersecurity risks associated with devices.

An official in FDA’s medical device center announced the agency has launched a new project intended to encourage device stakeholders to partner with cybersecurity researchers -- also called white hat hackers -- as a means of boosting the resilience, transparency and trustworthiness of medical devices and the health care system overall.