The HITECH Act—including the HITECH Final Rule’s provisions about HIPAA, data privacy, security, and breach notification—is an issue we have covered in detail previously. According to a June 17, 2015 press release, the former CFO of the Shelby Regional Medical Center in Texas has pleaded guilty to making a false statement in “representing that the … Continue Reading
The U.S. Department of Health and Human Services, Office for Civil Rights (OCR) recently announced a $150,000 settlement of potential violations of the HIPAA Security Rule by Anchorage Community Mental Health Services (ACMHS). These potential violations were caused by a malware breach of ACMHS's information technology resources. OCR's subsequent investigation of the breach found that ACMHS's preventative security measures prior to the breach were insufficient, and the settlement includes a Resolution Agreement with a corrective action plan for ACMHS to improve its security measures.… Continue Reading
The Department of Health & Human Services (HHS) released on September 19, 2013 guidance on financially remunerated prescription refill reminders.
The release of the guidance follows an announcement September 11, 2013, that HHS has decided not to enforce the restrictions on financially remunerated prescription refill reminders until November 7, 2013, 45 days after the general HITECH compliance date of September 23, 2013. HHS' decision to delay enforcement came on the heels of a lawsuit filed by Adheris, Inc., a Massachusetts company that provides prescription refill reminders. The lawsuit challenges the constitutionality of the HITECH Final Rule's restrictions on remunerated prescription refill reminders.… Continue Reading
On September 5, 2013, Adheris, Inc. ("Adheris"), a Massachusetts company that provides, among other services, prescription refill reminders, filed a lawsuit in the U.S. District Court for the District of Columbia against Kathleen Sebelius, Secretary of Health & Human Services ("Secretary"), and the Department of Health & Human Services ("HHS"), challenging the constitutionality of the HITECH Final Rule's restrictions on remunerated prescription refill reminders. Contemporaneous with its lawsuit, Adheris filed a Motion for Preliminary Injunction seeking to enjoin the Secretary's enforcement of these restrictions, which was set to begin on September 23, 2013.
In a joint motion filed by the parties today seeking to suspend the court's schedule on the Motion for Preliminary Injunction, the Secretary and HHS have informed the court that HHS expects to release guidance by September 23, 2013, on the HITECH Final Rule's "reasonable in amount" restriction applicable to financially remunerated prescription refill reminders. The Secretary has also decided not to enforce the restrictions on financially remunerated prescription refill reminders until November 7, 2013, 45 days after the general HITECH compliance date of September 23, 2013.… Continue Reading
Who knew that photocopiers stored information? Apparently "CBS Evening News" did, and now an April 2010 investigative report has led to a million-dollar HIPAA settlement.
Affinity Health Plan, Inc. (Affinity), a New York-based, not-for-profit health plan, agreed to pay the Office for Civil Rights (OCR) $1,215,780 to settle potential violations of the Health Information Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules. The settlement resulted from a breach self-report by Affinity, which first learned of the electronic protected health information (PHI) stored on its formerly leased photocopier's hard drive from "CBS Evening News" (CBS).… Continue Reading
On January 25, 2013, the Office for Civil Rights of the United States Department of Health and Human Services published the long-awaited final regulation implementing much of the amendments and additions to the HIPAA Privacy, Security, Breach Notification, and Enforcement Rules directed by the 2009 Health Information Technology for Economic and Clinical Health Act ("HITECH Act").
Noteworthy provisions of the HITECH Final Rule include:
- Making Business Associates directly liable for compliance with certain requirements of the HIPAA Privacy and Security Rules;
- Converting subcontractors of Business Associates that create, receive, maintain, or transmit PHI on behalf of the Business Associate into Business Associates themselves;
- Requiring authorizations for all treatment and health care operations communications where the Covered Entity receives financial remuneration for making the communications from a third party whose product or service is being marketed;
- Replacing the Breach Notification Rule's "harm" threshold with a presumption that an impermissible use or disclosure of PHI is a Breach unless the Covered Entity or Business Associate demonstrates that there is a low probability that the PHI has been compromised; and
- Mandating compliance by Covered Entities and Business Associates with applicable requirements by September 23, 2013.… Continue Reading
The Office for Civil Rights ("OCR") of the Department of Health and Human Services released today the long awaited, and much anticipated, omnibus final rule modifying the HIPAA Privacy, Security, Breach and Enforcement Rules. The final rule, which implements the statutory requirements of the Health Information Technology for Economic and Clinical Health Act ("HITECH") and the Genetic Information Nondiscrimination Act ("GINA"), is comprised of four final rules and addresses the July 2010 HITECH proposed rule, the Breach Notification and Enforcement interim final rules, as well as the October 2009 GINA proposed rule (collectively, the "HITECH Final Rule"). Notably, the HITECH Final Rule does not address the May 2011 proposed accounting and access report rule.… Continue Reading
On January 2, 2013, the HHS Office for Civil Rights ("OCR") announced its first settlement and corrective action plan following a breach affecting fewer than 500 individuals. The Hospice of North Idaho ("HONI") has agreed to pay $50,000 to settle potential violations of the HIPAA Security Rule following the theft of an unencrypted laptop containing electronic Protected Health Information ("ePHI") for 441 patients. Significantly, this is the third settlement in six months involving unencrypted portable devices.… Continue Reading
It has been almost two and half years since the Department of Health and Human Services, Office for Civil Rights ("OCR"), published a notice of proposed rulemaking to implement the statutory requirements of the Health Information Technology for Economic and Clinical Health Act ("HITECH") and amend the HIPAA Privacy and Security Rules, and almost nine months since the final rule was submitted to the Office of Management and Budget ("OMB") for final regulatory clearance. While industry speculation, fueled by comments made by Leon Rodriguez, the Director of OCR, at the annual Safeguarding Health Information: Building Assurance through HIPAA Security Conference, suggested that an omnibus final rule would be released by the end of summer, OMB had different ideas.… Continue Reading
The Office of Civil Rights (OCR) released guidance on Monday, November 26, 2012, regarding methods to de-identify protected health information in compliance with the HIPAA Privacy Rule. This guidance, which followed a June 2012 Government Accountability Office Report criticizing the delayed publication of this and related guidance, is aimed to assist covered entities and business associates in understanding what de-identification is and how de-identified information is created.… Continue Reading