Tag Archives: cybersecurity

Roundup of Recent Congressional Health Policy Hearings

A number of Congressional committees have recently held hearings on health policy issues, including the following: House Energy and Commerce Committee hearings on “Cybersecurity in the Heath Care Sector: Strengthening Public-Private Partnerships” and Food and Drug Administration (FDA) medical device user fees. A House Oversight and Government Reform Committee hearing on “Federally Funded Cancer Research: … Continue Reading

Recent Congressional Health Policy Hearings

Recent Congressional hearings focusing on health policy topics include the following: House Energy and Commerce Committee hearings on HHS cybersecurity responsibilities, Medicare and Medicaid program integrity, the Administration’s proposed Medicare Part B drug payment model, and patient-focused health insurance reforms. House Ways and Means Committee hearings on implementation of the Medicare Access & CHIP Reauthorization … Continue Reading

FDA Issues Postmarket Cybersecurity Recommendations for Medical Devices

On January 22, 2016, the federal Food and Drug Administration (“FDA”) issued a draft guidance outlining postmarket recommendations for medical device manufacturers to address cybersecurity risks.  The draft guidance details the agency’s specific recommendations, which address monitoring, identifying and managing cybersecurity vulnerabilities in medical devices that are software, or contain software (including firmware) or programmable … Continue Reading

FDA to Hold Medical Device Cybersecurity Workshop (Jan 20-21)

As discussed on our sister Life Sciences Legal Update blog, the FDA is holding a public two-day workshop entitled “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity” on January 20-21, 2016. The FDA seeks to bring together diverse stakeholders to highlight past collaborative efforts, identify tools to aid stakeholders in implementing disclosure and vulnerability management, … Continue Reading

FDA Releases Final Medical Device Cybersecurity Guidance, Schedules Workshop on Topic

Yesterday the FDA issued final guidance entitled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” which includes recommendations for medical device manufacturers on cybersecurity management and information that should be included in a pre-market submission. The recommendations are intended to supplement previous FDA guidances, “Guidance for the Content of Premarket Submissions for Software … Continue Reading

OIG Concludes OCR Slow to Enforce HIPAA Security Rule and Comply with Cybersecurity Requirements

The OIG has concluded that the HHS Office for Civil Rights (OCR) is not adequately overseeing and enforcing the HIPAA Security Rule. In short, the OIG found that OCR failed to provide for periodic audits, as mandated by HITECH, to ensure that covered entities were in compliance with the Security Rule, and instead continued to … Continue Reading

Draft FDA Guidance Recommends Cybersecurity Risk Assessments and Management Plans for Premarket Medical Device Submissions

The Food and Drug Administration (FDA) has announced the availability of a new draft guidance document entitled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.” The draft guidance identifies cybersecurity issues that medical device manufacturers should consider in preparing premarket submissions for medical devices – including Premarket Notifications (510(k)), Premarket Approval Applications … Continue Reading
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