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 Specifically, the agency issued Draft Guidance requiring the submission of cyber security materials as part of...more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

FDA Flexes Mobile App Enforcement Muscles (Gently)

The FDA was granted authority to regulate mobile health care applications (apps) as part of the Food and Drug Administration and Innovation Act. (For a detailed discussion of the FDA’s authority, see “FDA Safety and...more

6/24/2013 - FDA Healthcare Mobile Apps Telemedicine

OCR Settles with Shasta Regional Medical Center for $275,000

The HHS Office of Civil Rights (OCR) recently announced a $275,000 settlement with Shasta Regional Medical Center (SRMC) on the heels of an investigation triggered by a Los Angeles Times article indicating that senior...more

6/21/2013 - Healthcare HHS HIPAA Hospitals Media OCR PHI Public Disclosure Settlement

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

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