Category Archives: Healthcare Privacy

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FDA Issues New Draft Cybersecurity Guidance for Medical Devices

The Food & Drug Administration has recently released for comment a draft expansion of guidance regarding Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Although the FDA issued existing guidance in 2014, the new guidance reflects concerns about the rapidly-changing nature of cybersecurity threats, and the potentially grave consequences of cybersecurity incidents … Continue Reading

Texas Hospital Order to Pay $4.3M for Failure to Implement its HIPAA Security Policies

A Texas hospital was recently ordered by an administrative law judge to pay a $4,300,000 penalty for three data breaches over the course of 2012 and 2013 that exposed the personal health information – including social security numbers, patient names and treatment records – of more than 33,000 individuals in violation of HIPAA. The specific … Continue Reading

New York Settles EmblemHealth Breach for $575,000

The recent $575,000 settlement with EmblemHealth signals a push from AG Schneiderman “for stronger security laws and hold[ing] businesses accountable for protecting their customers’ personal data.”  Noting New York’s “weak and outdated” security laws, AG Scheiderman used the settlement to urge for the swift passage of the Stop Hacks and Improve Electronic Data Security Act … Continue Reading

HHS-OCR Closes 2017 with Six Figure Settlement in PHI Data Breach Impacting Over 2 Million Individuals

At the end of last year the Department of Health and Human Services – Office for Civil Rights announced its resolution agreement and settlement with 21st Century Oncology for $2.3 million. The company, which billed itself as the largest operator of cancer treatment centers in the world, filed for bankruptcy in May of 2017.  OCR’s … Continue Reading
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