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Cybersecurity

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Medical device experts voiced their approval of FDA's recent draft guidance that lays out how device manufacturers should address cybersecurity in their premarket submissions.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

October 01, 2018 | Daily News

FDA Commissioner Scott Gottlieb announced three new initiatives aimed at increasing cybersecurity preparedness and information-sharing among medical device stakeholders, particularly among health care delivery organizations (HDOs) such as hospitals.

September 25, 2018 | Daily News

The House on Tuesday (Sept. 25) passed its hazard preparedness reauthorization bill by voice vote.

September 11, 2018 | Daily News

Device industry and cybersecurity lawyers plan to soon unveil an in-depth report describing a pathway for medical device manufacturers and the wider health care sector to protect against cybersecurity threats.

July 03, 2018 | Daily News

A major hospital group says FDA needs to step up and mandate cybersecurity for medical devices, a move intended to address risks related to legacy products that can't be updated or adequately patched as Congress considers steps to protect patients from cyber attacks.

June 11, 2018 | Daily News

House lawmakers introduced a draft hazard preparedness reauthorization bill that would enhance FDA’s emergency use authorities and direct the agency to work toward developing medical countermeasures with regard to cybersecurity threats.

June 06, 2018 | Daily News

In an unusual show of bipartisanship, key lawmakers from the Senate and House sent a letter to HHS Secretary Alex Azar that castigates the department for failing to follow through on key provisions of the Cybersecurity Act of 2015, which tasked HHS with developing industry-based approaches to mitigating cyber attacks.

April 17, 2018 | Daily News

FDA's device center may ask Congress for authority to require medical device makers build cybersecurity into their upfront product designs and, once a product is marketed, to disclose any vulnerabilities as they are identified.

April 12, 2018 | Daily News

FDA is seeking $70 million to create a Center of Excellence on Digital Health, which would be tasked with crafting a new regulatory approach toward these products, akin to what FDA is already piloting with its software pre-cert program, according to budget material sent to congressional appropriators.

April 03, 2018 | Daily News

The American Medical Association is urging HHS to put out a policy that would encourage physicians to embrace a framework for managing cybersecurity risks in exchange for the government agreeing not to conduct surprise audits under the Health Insurance Portability and Accountability Act, which governs the handling and use of medical records and personal patient information.

April 03, 2018 | Daily News

An FDA-sponsored survey on enhanced cybersecurity for medical devices has found competing influences -- from regulatory requirements to purchasing demands -- that must be overcome to ensure device safety and improved medical treatments.

March 30, 2018 | Daily News

The Federal Trade Commission's chief of privacy and identity protection is recommending the use of contracts and oversight of vendors to minimize the cybersecurity risks of handling medical information and personal health records.

March 29, 2018 | Daily News

HHS Secretary Alex Azar is being pressed to weigh in on a dispute over alleged mismanagement of the department's recently established cyber-threat sharing center, which is undergoing a restructuring that a leading HHS cybersecurity official says could undermine the department's ability to assist the health sector in anticipating and responding to cyber attacks.

March 14, 2018 | Daily News

The former director of the Obama administration's cybersecurity commission is cautioning the health industry about moving too quickly to data-driven innovations and automation without adequate security consideration, advice that comes as the industry faces increased ransomware and other denial of service attacks.

March 08, 2018 | Daily News

The Healthcare Information and Management Systems Society in its third annual cybersecurity survey found the Department of Homeland Security's National Cybersecurity and Communications Integration Center ranked among the bottom third of sources for cyber threat intelligence, with “word of mouth” at the top with nearly 70 percent of respondents.

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