Edward G. Zacharias

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Edward (Ed) G. Zacharias focuses his practice on complex transactions and regulatory compliance matters. He represents hospitals and health systems, academic medical centers, physician group practices, post-acute care providers, health information technology vendors, biotech companies, insurers, pharmaceutical companies and a variety of other health care entities. Read Edward Zacharias' full bio.

Latest Articles

Lack of a sufficient risk analysis continues to be one of the most commonly alleged violations in Office for Civil Rights (OCR) HIPAA enforcement actions, appearing in half of all OCR settlements announced in the last 12 months and in almost all of the $1 million-plus settlements during that time period. Significant confusion remains across the health care industry as to what actually constitutes a compliant risk analysis for purposes of the HIPAA Security Rule.…
The US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) recently posted guidance (OCR guidance) clarifying that a business associate such as an information technology vendor generally may not block or terminate access by a covered entity customer to protected health information (PHI) maintained by the vendor on behalf of the customer. Such “information blocking” could occur, for example, during a contract dispute in which a vendor terminates customer access or…
On September 29, 2015, the U.S. Department of Health and Human Services Office of the Inspector General (OIG), Office of Evaluation and Inspections, released two studies calling on the HHS Office for Civil Rights (OCR) to strengthen its efforts in both general enforcement of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Standards and enforcement of security breach reporting requirements. OIG commissioned both studies out of concern for the increased risk of an invasion…
HIPAA covered entities have reported that the HHS Office for Civil Rights recently sent pre-audit screening surveys to a pool of covered entities that may be selected for the previously delayed second phase of HIPAA compliance audits. This On the Subject describes the phase two audit program and identifies steps that covered entities and business associates should take to prepare for these audits. Read the full article.…
The U.S. Department of Health and Human Services, Office for Civil Rights (OCR) recently transmitted HIPAA pre-audit screening surveys to covered entities that may be selected for a second phase of HIPAA compliance audits (Phase 2 Audits). OCR is required to conduct compliance audits of covered entities and business associates under the 2009 Health Information Technology for Economic and Clinical Health Act. Unlike the pilot audits conducted in 2011 and 2012 (Phase 1 Audits), which…
Following an Office for Civil Rights investigation, Anchorage Community Mental Health Services, Inc., agreed to pay $150,000 and comply with a two-year Corrective Action Plan to settle allegations that it violated the HIPAA Security Rule. This settlement is another reminder that covered entities and business associates should take the necessary steps to ensure compliance with HIPAA and to reasonably and appropriately safeguard the electronic protected health information in their possession. Read the full article.
The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) will soon begin a second phase of audits (Phase 2 Audits) of compliance with Health Insurance Portability and Accountability Act of 1996 (HIPAA) privacy, security and breach notification standards (HIPAA Standards) as required by the Health Information Technology for Economic and Clinical Health (HITECH) Act. Unlike the pilot audits during 2011 and 2012 (Phase 1 Audits), which focused on covered entities, OCR…
In building a stout privacy and security compliance program that would stand up well to federal HIPAA audits, proactive healthcare organizations are generally rewarded when it comes to data breach avoidance and remediation. But an important piece of that equation is performing consistent risk analyses. McDermott partner, Edward Zacharias, was interviewed by HealthITSecurity to discuss these topics and more. Read the full interview.…
“Heartbleed” has been all over the news, and companies have been scrambling to respond.  What sounds like a nasty medical condition is actually a recently discovered flaw in popular encryption software called OpenSSL.  It has been widely reported in the news outlets that approximately 60 percent of all web servers use OpenSSL.  According to the Federal Trade Commission, the flaw can permit a hacker to unlock the encryption and “monitor all communication to and…
In Boston, we celebrated Data Privacy Day (January 28) by presenting “U.S. Privacy and Data Protection: 2013 Year In Review and a Prediction of What’s to Come in 2014” for participants in an IAPP KnowledgeNet.  Our panel of speakers discussed significant U.S. data privacy and protection events from 2013 and shared thoughts about what’s ahead for 2014 in U.S. data privacy and protection.  You may download the presentation slides here. We hope you find…