Hogan Lovells Publications

HIPAA penalty caps to be reduced and tied to culpability level

In a dramatic turn, the U.S. Department of Health and Human Services has announced that effective immediately, penalties for many Health Insurance Portability and Accountability Act (HIPAA) ...


Recap of the OCR/NIST Conference on Safeguarding Health Information

Regulators provided key insights into enforcement trends and potential changes to HIPAA regulations at the 11th Annual “Safeguarding Health Information: Building Assurance Through...

Hogan Lovells Publications

Proposed changes to FDA guidance for the content of premarket submissions for management of cybersecurity in medical devices: What you should know

October is National Cybersecurity Awareness Month and the Food and Drug Administration (FDA or the agency) has been busy.

Hogan Lovells Publications

Best practices for managing cybersecurity risks related to IoT-connected medical devices

Connected medical devices deliver numerous benefits not available before, including improved monitoring of patient welfare and a wealth of vital data. But for all the advantages available...

Hogan Lovells Publications

SEC issues new interpretive guidance on cybersecurity disclosures

Prompted by concern over the increase in the risks and frequency of data breach incidents and other cyber-attacks affecting public companies, the Securities and Exchange Commission recently ...

Hogan Lovells Publications

Working together: FDA releases final guidance on interoperability

On September 6, 2017, the Food and Drug Administration (FDA or the Agency) released its final guidance document, Design Considerations and Pre-Market Submission Recommendations for...

Hogan Lovells Publications

Internet of Things Cybersecurity Improvement Act of 2017

On 1 August 2017, a bipartisan group of four U.S. senators –Steve Daines (R-MT), Cory Gardner (R-CO), Mark Warner (D-VA), and Ron Wyden (D-OR) – introduced the Internet of ...

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