This week’s issue of the New England Journal of Medicine features two interesting articles about the federal HITECH Act and its role in promoting electronic health records: The HITECH Era and the Path Forward, and The HITECH Era in Retrospect. More
Tag Archives: HITECH
HIPAA Compliant Technology and the Importance of Encryption
We welcome this guest blog by Gene Fry, Compliance Officer, Scrypt, Inc.
The Health Insurance Portability and Accountability Act (HIPAA) sets the standard for protecting sensitive patient data. This means that any covered entity (CE) or business associate (BA) that deals with protected health information (PHI) must ensure that all the required physical, network, and process security measures are in place and followed. The HIPAA Privacy Rule addresses the storage,… More
HHS OCR Cites Faulty Risk Analysis, Lack of Policies in Addition to Breach by Physician Practice
In what may be a sign of things to come, a recent HHS OCR resolution agreement with a dermatology practice cites not only the loss of some 2,200 records on a thumb drive, but the lack of an “accurate and thorough analysis of the potential risks and vulnerabilities to the confidentiality of ePHI” and “[t]he Covered Entity did not … have written policies and procedures and train members of its workforce”;… More
HHS OCR Issues HIPAA Guidance on Refill Reminders, Decedent Information, Disclosure of Proof of Student Immunications and Delays CLIA Lab Enforcement
Late last night, HHS OCR issued its anticipated guidance on “The HIPAA Privacy Rule and Refill Reminders and Other Communications about a Drug or Biologic Currently Being Prescribed for the Individual.” A new “Fact Sheet” and corresponding “Frequently Asked Questions” attempt to explain how the refill reminder exception to the marketing rule works, and seek to address both the scope of communications that fall within the exception,… More
HIPAA Unconstitutional? Maybe Not, But New Marketing Regulations Are Coming
You may have seen the recent lawsuit alleging that HIPAA’s marketing regulations are unconstitutional. In that case, the plaintiff is a company that “provides a refill reminder service and other adherence messaging services,” Adheris, Inc.
Adheris sued the Department of Health and Human Services because HIPAA’s regulations threaten to put it out of business. In particular, HIPAA now requires patient authorizations for its kind of patient reminders. … More
Protecting Health Information: Health Data Security Training
It was a pleasure to be on a panel with members of the Massachusetts Office of the Attorney General last week at the Massachusetts Medical Society to talk about how physicians can protect health information in our presentation entitled: “Protecting Health Information: Health Data Security Training.” We covered the latest in federal law (HIPAA, HITECH) and Massachusetts law. More
$1.5 Million Settlement of First HIPAA Enforcement Action Resulting from HITECH Breach Notification Rule
The trend toward increasingly large health information breach settlements has continued with yesterday’s announcement thatBlue Cross Blue Shield of Tennessee (BCBST) has agreed to pay the U.S. Department of Health and Human Services (HHS) $1,500,000 to settle potential violations of HIPAA’s Privacy and Security Rules, HHS’s Office of Civil Rights. BCBST also agreed to a corrective action plan to address gaps in its HIPAA compliance program.… More
Data Security and Privacy for Medical Device, Pharmaceutical and Life Sciences Companies
Earlier today, I delivered a presentation on "Data Security and Privacy for Medical Device, Pharmaceutical and Life Sciences Companies: How to manage your obligations under HIPAA, the HITECH Act and other federal and state data privacy and security laws" with colleagues Ara Gershengorn and Sarah Altschuller. More
HHS Fines Cignet Health $4.3 Million for HIPAA Violations
Earlier today, the U.S. Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) issued a Notice of Final Determination finding that Cignet Health of Prince George’s County, Md., (Cignet) violated the Privacy Rule of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). HHS imposed a civil money penalty (CMP) of $4.3 million for the violations, representing what OCR said was "the first CMP issued by the Department for a covered entity’s violations of the HIPAA Privacy Rule." … More
HHS Proposes Major Changes to HIPAA Privacy, Security and Enforcement Rules
On July 8, 2010, the Department of Health and Human Services (“HHS”) issued a notice of proposed rulemaking (“NPRM” or “proposed rule”)1 modifying the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy, Security, and Enforcement Rules2 pursuant to the Health Information Technology for Economic and Clinical Health Act (“HITECH”), which was enacted February 17, 2009 as part of the American Recovery and Reinvestment Act of 2009, Pub. L. 111-5.