Joshua Freemire

Joshua Freemire

Ober|Kaler

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FDA Recommends that Manufacturers Seeking Medical Device Approval Submit Cyber Security Plans

Last week, the FDA took steps to address a quietly growing concern regarding cyber security and medical devices. Specifically, the agency issued Draft Guidance requiring the submission of cyber security materials as part of...more

6/25/2013 - Cyber Attacks Cybersecurity Data Protection FDA Healthcare Malware Manufacturers Medical Devices

HITECH and HIPAA: The Final Rule

The final rule implementing new obligations under HITECH and changing obligations under HIPAA is finally out. Covered entities and business associates need to come into compliance with these requirements by September 23,...more

3/14/2013 - Business Associates Data Breach Data Protection GINA Healthcare HIPAA HITECH Notice Requirements PHI

HHS Overhaul of HIPAA: Summary of New Obligations for Covered Entities and Business Associates

On January 17, 2013, the Department of Health and Human Services (HHS) posted Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules [PDF] (the Final Rule) under the authority of the HITECH...more

1/24/2013 - Business Associates Covered Entities Data Breach Data Protection Disclosure Requirements Enforcement Fundraisers GINA HIPAA HIPAA Omnibus Rule HITECH Marketing PHI Privacy Policy Subcontractors Third-Party

Guidance on De-Identified Protected Health Information Offers In-depth Instruction on Technical Issues

The HITECH Act required the Secretary of Health and Human Services to publish a number of “Guidance” documents to inform the health care industry and its advisors about practical aspects of HIPAA compliance and HITECH...more

1/8/2013 - Data Protection De-Identified Protected Health Information HHS HIPAA HITECH OCR Technology

First OCR Settlement Involving a “Small” Breach Focuses on Mobile Device Security

In what is best understood as a follow-up to both the recent settlement with MEEI and the release of its mobile device security guidance, HHS OCR recently released details of a settlement reached with the Hospice of Northern...more

1/7/2013 - Compliance Data Breach Data Protection Health Information Technologies HHS HIPAA HONI Mobile Devices OCR Patient Confidentiality Breaches Settlement

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