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National Institute of Standards and Technology (NIST) has published draft recommendations aimed at securing the confidentiality of sensitive federal information located within non-federal entities’ information technology...more
Earlier this year, the U.S. Department of Health and Human Services Office of Civil Rights ("OCR") announced its plan for a number of audits regarding compliance with the Health Insurance Portability and Accountability Act of...more
In a pair of recent cases, two California health care providers successfully warded off lawsuits arising from unauthorized data breaches of patient files. These cases illustrate that improper disclosure of electronically...more
The 2015 Work Plan of the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted on Friday, October 31, 2014, includes initiatives focused on testing information security controls related to...more
The Health Information Technology for Economic and Clinical Health Act (HITECH Act) and subsequent regulations have changed several aspects of compliance with HIPAA, including the way covered entities should think about...more
Dr. David Relman, a professor of infectious disease, microbiology and immunology at Stanford University's medical school, was quoted recently saying of the Ebola virus: “As best we can tell right now, it is quite possible...more
The Chinese market presents a tremendous opportunity for U.S. hospitals and providers, as long as the intricacies of data privacy and security issues are thoroughly understood. This includes Chinese regulations regarding...more
On October 21-22 the U.S. Food and Drug Administration (FDA), in collaboration with the U.S. Departments of Health and Human Services and Homeland Security, conducted a public workshop entitled “Collaborative Approaches for...more
On Oct. 31, 2014, the Office of e-Health Standards and Services, which is charged with HIPAA compliance, announced an enforcement delay to the regulations requiring the use of the Health Plan Identifiers (HPIDs) in HIPAA...more
This past weekend the U.S. Department of Health and Human Services (HHS) indefinitely delayed enforcement of the requirement that all self-insured health plans obtain a Health Plan Identifier number (HPID). ...more
On Halloween, the Department of Health and Human Services announced an indefinite delay in enforcement of the health plan identifier (HPID) rules. As a result, large health plans are no longer required to choose whether to...more
The Health Plan Identifier (“HPID”) is a standard, unique health plan identifier required by the Health Insurance Portability & Accountability Act of 1996 (“HIPAA”). On September 5, 2012, the Department of Health and Human...more
In a surprise move, the Centers for Medicare & Medicaid Services (CMS) announced an indefinite delay in enforcement of regulations pertaining to “health plan enumeration and use of the Health Plan Identifier (HPID) in HIPAA...more
On October 28, 2014, the California Attorney General (“AG”) released its second annual report detailing the security breaches reported to the AG’s office in 2013, and provided recommendations to both the industry and...more
On October 30, 2014, the Centers for Medicare and Medicaid Services (“CMS”) announced the procedure for applicable manufacturers and group purchasing organizations (“GPOs”) to report payment and ownership information that was...more
California Attorney General Kamala D. Harris has released a “California Data Breach Report,” which presents a series of findings and recommendations based on a review of breaches reported to the Attorney General’s office in...more
On October 28, 2014, Attorney General Kamala Harris released the second annual California Data Breach Report. The report detailed the nature and scope of data breach notifications that her office received in 2013. Her office...more
This week, the Privacy and Security Workgroup within the Health IT Policy Committee was tasked by the U.S. Department of Health and Human Services (“HHS”) to discuss certain patient data protections. Specifically, they were...more
Certain group health plans are required to obtain a 10-digit Health Plan Identifier ("HPID") from the Center for Medicare and Medicaid Services ("CMS") by November 5, 2014. Currently various users of the health care system...more
Overview and General Principles -
On October 2, 2014, the Food and Drug Administration (“FDA”) finalized guidance describing the FDA’s position on cybersecurity standards for medical devices. The guidance discusses...more
Last week, the HHS Office of Inspector General released a damning report on FDA’s data security: “The objective of this review was to determine whether the FDA’s network and external Web applications were vulnerable to...more
The National Institute of Standards and Technology (NIST) and the Department of Health and Human Services (HHS), Office for Civil Rights (OCR) recently highlighted the importance of protecting health information at the...more
A company named SLC Security, LLC (“SLC”), recently announced that it will begin notifying individuals if it believes it has identified a security breach or vulnerability of a company and it has not received a satisfactory...more
The Food and Drug Administration (FDA) issued guidelines this month recommending that manufacturers develop a set of cybersecurity controls in the design of medical devices capable of connecting to the Internet, a network, or...more
On October 2, 2014, the U.S. Food and Drug Administration (FDA) issued its final guidance on cybersecurity for medical device manufacturers, titled “Content of Premarket Submissions for Management of Cybersecurity in Medical...more
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