Category: Health Care

New FDA Guidance on Waiver of Informed Consent for Minimal Risk Investigations

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The FDA recently issued new guidance that allows institutional review boards (IRBs) to waive or alter the FDA’s informed consent requirements for certain minimal risk clinical investigations without objection from the FDA.

The statutory basis for the guidance comes from amendments made by the 21st Century Cures Act from late in 2016 (P.L 144-255). This guidance, which took effect on July 25, 2017, is the first step for the FDA on this issue.  The FDA intends to implement subsequent regulations to permit IRB waiver or alterations of informed consent requirements for minimal risk clinical investigations.

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OCR Responds to Rise in Health Care Cyberattacks

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After recent WannaCry ransomware and Petya/notPetya malware attacks exposed the data security vulnerabilities of health care organizations and pharmaceutical companies globally, the Department of Health and Human Services and Office for Civil Rights have rolled out resources to prevent future attacks. The OCR’s resources, such as its Quick-Response Checklist, infographic and informational newsletter, are meant to support health care organizations every step of the way, from planning and contingency plans to response and mitigation procedures.

We’ve outlined some of the key points in the OCR and HHS documents in this recent alert.

Time to Focus on Cybersecurity in Health Care

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In the wake of the WannaCry global attack that impacted the U.K.’s National Health Service, the need to protect valuable health care data has never been more urgent. The U.S. government has begun to take steps in the right direction with the passing of executive orders on cybersecurity, the Cybersecurity Act of 2015, and the Government Accountability Office report on the Internet of Things.

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Disrupting the Health Care Cybersecurity Model (or Lack Thereof): Health Care Industry Cybersecurity Task Force Calls Out Regulatory Barriers

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In a previous blog post, our team evaluated the draft recommendations prepared by the Health Care Industry Cybersecurity Task Force in its “Report on Improving Cybersecurity in the Health Care Industry.”  

We recently examined three of the six major recommendations in the report and their potential impact on the existing health care regulatory environment. These include:

  • HHS and a Comprehensive Health Care Security Framework
  • Government and Private Incentives to Migrate Vulnerable Health Care Providers to More Secure Environments
  • Development of Fraud and Abuse Exemptions to Foster Collaboration and Permit Shared Resources

For more insight, read our detailed review of the health care security recommendations above.

An Early Review of the Trump Administration’s Health Care Cybersecurity Task Force Report

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Formed by the Cybersecurity Act of 2015, a task force established to share cybersecurity information between federal government and private industry representatives has released its “Report on Improving Cybersecurity in the Health Care Industry.” They presented six major action items for Congress, the Department of Health and Human Services, other government agencies and private industry.

The Report organized its recommendations under six Imperatives:

  • Define and streamline leadership, governance, and expectations for health care industry cybersecurity;
  • Increase the security and resilience of medical devices and health IT;
  • Develop the health care workforce capacity necessary to prioritize and ensure cybersecurity awareness and technical capabilities;
  • Increase health care industry readiness through improved cybersecurity awareness and education;
  • Identify mechanisms to protect research and development efforts and intellectual property from attacks or exposure; and
  • Improve information sharing of industry threats, weaknesses, and mitigations.

In a recent alert, we evaluated the action items and draft recommendations prepared by the Task Force, = and discuss how the Trump administration will react to these new proposals.

Read our review of the Health Care Cybersecurity Task Force Report

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