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June 21, 2021 | Daily News

FDA is taking steps to address key medical device servicing issues, including by publishing a highly anticipated remanufacturing draft guidance that aims to draw a clear line between medical device servicing and remanufacturing activities and ensure original device manufacturers and third-party device servicers adhere to agency standards for fixing and updating medical devices.

April 07, 2021 | Daily News

As the Biden administration works to draft guidance for industry around COVID-19 vaccine passports -- digital health passes that can provide proof of vaccination and be used by businesses to screen people for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.

March 05, 2021 | Daily News

FDA on Friday (March 5) granted emergency use authorization to the first non-prescription molecular COVID-19 test for at-home use.

February 23, 2021 | Daily News

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.

December 12, 2020 |

Officials from the Centers for Disease Control and Prevention are working to revise allergy warnings for Pfizer’s COVID-19 vaccine to make clear that not everyone with allergies should avoid getting the vaccine, as some CDC advisers worry the language in Pfizer’s fact sheets, which were cleared by FDA, and in proposed CDC guidance will deter the public and health care providers from taking and administering the shot.

December 01, 2020 | Daily News

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.

May 20, 2020 | Daily News

Many nursing homes had infection control deficiencies long before the COVID-19 pandemic hit, the Government Accountability Office says in a new report Wednesday (May 20).

May 11, 2020 | Daily News

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.

April 15, 2020 | Daily News

With millions of Americans laid off or facing reduced hours, wide-ranging stakeholders have floated several proposals aiming at ensuring loss of employment does not equate to loss of insurance coverage.

January 07, 2020 | Daily News

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.

October 02, 2019 | Daily News

Health IT, provider and hospital groups called on Senate health committee leaders to slow down an Office of the National Coordinator for Health IT’s proposed interoperability rule until ONC resolves outstanding concerns and issues groups have with the proposal.

October 01, 2019 | Daily News

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.

September 18, 2019 | Daily News

FDA is launching a sweeping data modernization plan in a bid to make its regulatory practices more efficient and to keep pace with rapid developments in biomedical technology and the use of real-world evidence.

September 09, 2019 | Daily News

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.

July 16, 2019 | Daily News

The Government Accountability Project, a whistleblower protection group, has filed suit against HHS seeking a federal court order for documents and information related to a years-long dispute over the establishment, and then restructuring, of HHS' cybersecurity center.

July 03, 2019 | Daily News

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.

March 19, 2019 | Daily News

Medical device industry lobby groups are asking FDA to make major changes to the draft premarket cybersecurity guidance it released in October, questioning the agency’s proposed two-tier risk system, Cybersecurity Bill of Materials and one-size-fits-all approach.

January 30, 2019 | Daily News

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.

January 29, 2019 | Daily News

An FDA official on Tuesday (Jan. 29) told a group of stakeholders that legacy medical devices remain an “intractable challenge” for promoting cybersecurity in the medical device space, a view also held by agency chief Scott Gottlieb who, on the same day, stated that one of FDA’s most critical challenges lies in addressing safety risks posed by the devices.

January 04, 2019 | Daily News

Greg Garcia, executive director for cybersecurity of the Healthcare and Public Health Sector Coordinating Council, says the group will be gearing up over the next few weeks to encourage widespread adoption of recently issued cybersecurity guidelines, as it also develops a process for measuring the effectiveness of the voluntary guidance for reducing cyber risks for hospitals, patients and the rest of the medical community.