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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.

January 02, 2019 | Daily News

HHS and the healthcare industry issued cybersecurity “best practices” that focus on baseline measures such as protecting emails, limiting system access and developing incident response plans -- based on a pre-testing process intended to assess the effectiveness of the security guidelines.

January 02, 2019 | Daily News

HHS and the healthcare industry issued cybersecurity “best practices” that focus on baseline measures such as protecting emails, limiting system access and developing incident response plans -- based on a pre-testing process intended to assess the effectiveness of the security guidelines.

December 05, 2018 | Daily News

The American Hospital Association and a wide range of health care stakeholders urged congressional leaders to pass a key health security bill before the end of the lame-duck session, arguing that, without reauthorization from lawmakers, essential HHS emergency preparedness authorities will expire and gaps in federal response programs will remain unfilled.

November 08, 2018 | Daily News

FDA and the HHS Office of Inspector General are butting heads over whether the agency is equipped to address postmarket cybersecurity risks to medical devices.

November 01, 2018 | Daily News

HHS has rebranded its cybersecurity center to distinguish it in the department's efforts to defend the health care sector's information technology infrastructure, an HHS spokesperson told Inside Health Policy.

October 25, 2018 | Daily News

Medical device experts voiced their approval of FDA's recent draft guidance that lays out how device manufacturers should address cybersecurity in their premarket submissions.

October 24, 2018 | Daily News

A key House health care committee suggested Tuesday that Congress bolster efforts by federal regulators to get medical device makers and other industries to ferret out cybersecurity vulnerabilities by offering a liability shield for independent cybersecurity researchers when vulnerabilities are reported, and by helping to distinguish between hacking and good-faith efforts to discover security lags.

October 18, 2018 | Daily News

FDA and the Department of Homeland Security (DHS) have agreed to formally work together to stave off cybersecurity threats facing medical devices.

October 04, 2018 | Daily News

An array of stakeholders voiced their support for the cross-industry role laid out in a set of sweeping cybersecurity initiatives unveiled by FDA Commissioner Scott Gottlieb this week, including new cybersecurity information sharing agreements, a playbook for hospitals to prepare for cybersecurity breaches and plans for an updated agency guidance document.