On April 17, 2012, the HHS Office of Civil Rights (OCR) announced a settlement and corrective action plan with Phoenix Cardiac Surgery, P.C. (Phoenix), a small cardiology practice based in Phoenix and Prescott, Arizona. More specifically, Phoenix has agreed to pay $100,000 to settle allegations of HIPAA violations arising out of an investigation conducted by OCR.… Continue Reading
On March 13, 2012, the HHS Office of Civil Rights (OCR) announced the first enforcement action resulting from a breach self-report required by HITECH's Breach Notification Rule. Blue Cross Blue Shield of Tennessee (BCBST) has agreed to pay HHS $1,500,000 to settle potential violations of the HIPAA Privacy and Security Rules and has entered into a corrective action plan to address gaps in its HIPAA compliance program.
The HIPAA/HITECH Breach Notification Rule requires covered entities to report a breach (e.g., an impermissible use or disclosure of protected health information that compromises the security or privacy of the protected health information) to the affected individual(s), HHS and, at times, the media. OCR's investigation of BCBST followed a breach report submitted by BCBST informing HHS that 57 unencrypted computer hard drives were stolen from a leased facility in Tennessee. The hard drives contained the protected health information of more than 1 million individuals, including member names, social security numbers, diagnosis code, dates of birth, and health plan identification numbers.
According to OCR's investigation, BCBST failed to implement appropriate administrative and physical safeguards as required by the HIPAA Security Rule. More specifically, BCBST failed to perform the required security evaluation in response to operational changes and did not have adequate facility access controls.
In addition to the $1,500,000 settlement, the Resolution Agreement between BCBST and OCR requires BCBST to revise its Privacy and Security policies, conduct robust trainings for all employees, and perform monitor reviews to ensure compliance with the corrective action plan. BCBST did not admit any liability in the agreement and OCR did not concede that BCBST was not liable for civil monetary penalties.
Additional information about OCR's enforcement activities can be found at http://www.hhs.gov/ocr/privacy/hipaa/enforcement/examples/index.html.… Continue Reading
To implement the HITECH Act's mandate for the Office for Civil Rights (OCR) to perform HIPAA audits, OCR has just announced that it is piloting a program to perform up to 150 audits of covered entities to assess privacy and security compliance. Audits conducted during the pilot phase are planned to begin with an initial 20 audits between November 2011 and April 2012. The remaining audits are scheduled to conclude by December 2012. All covered entities and business associates are eligible for audits; however, OCR has indicated that it is focusing on covered entities (range in type and size) in the initial phase. Business associates will be included in future audits.… Continue Reading
Today the Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking implementing provisions of the HITECH Act related to accounting for disclosures of protected health information (PHI). Pursuant to the HITECH Act and its more general authority under HIPAA, HHS proposed to divide the Privacy Rule provisions related to an accounting into two separate individual rights: (1) an accounting and, (2) an access report.… Continue Reading
On May 16, 2011, the Office of Inspector General ("OIG") published a report with the results from its nationwide review of the Centers for Medicare and Medicaid Services ("CMS'") oversight of the Health Insurance Portability and Accountability Act of 1996 ("HIPAA"). In its review, the OIG sought to determine the sufficiency of CMS' oversight and enforcement actions pertaining to hospitals' implementation of the HIPAA Security Rule. Pursuant to the Security Rule, covered entities, such as hospitals, must implement technical, physical, and administrative safeguards for the protection of electronic protected health information ("ePHI"). According to the OIG, CMS' oversight and enforcement actions were "not sufficient," leaving limited assurance of the security of hospitals' ePHI.
The report details the results from the OIG's audits of seven hospitals. The audits disclosed "numerous internal control weaknesses." Specifically, the OIG identified 151 vulnerabilities in the systems and controls intended to protect ePHI. Of these vulnerabilities, 124 were categorized as "high impact." These vulnerabilities placed the confidentiality, integrity, and availability of ePHI at risk. The consequences of the high impact vulnerabilities is that it (1) may result in the highly costly loss of major tangible assets or resources; (2) may significantly violate, harm, or impede an organization's mission, reputation, or interest; or (3) may result in human death or serious injury.… Continue Reading
The Department of Health and Human Services (HHS) has announced that its development of a Final Breach Notification Rule (currently, the rule is in interim final form) has been stalled, as the final rule was withdrawn from consideration of the Office of Management and Budget in order for HHS to give further consideration to what the final rule should include. HHS has remained relatively quite regarding the development of a Final Breach Notification Rule, but has announced that it intends for a final rule to be published "in the coming months."… Continue Reading
HHS has just released its proposed rule modifying the HIPAA Privacy, Security, and Enforcement Rules to implement the privacy, security, and certain enforcement provisions of subtitle D of the Health Information Technology for Economic and Clinical Health Act (Title XIII of the American Recovery and Reinvestment Act of 2009). The advance version of the rule can be accessed here; the official version will be published July 14. A press release should be available later this morning.… Continue Reading
On May 28, 2010, just shy of the June 1st compliance deadline, the Federal Trade Commission announced that it would again be postponing enforcement of the Red Flags Identity Theft Prevention Rule through December 31, 2010. This delay comes at the request of Congress, which has been considering legislation (which has been referred to the Senate Committee on Banking, Housing, and Urban Affairs) that would affect the scope of entities covered by the Rule. The FTC "urges Congress to act quickly to pass legislation that will resolve any questions as to which entities are covered by the Rule and obviate the need for further enforcement delays." If Congress passes legislation limiting the scope of the Red Flags Rule with an effective date earlier than December 31, 2010, the Commission will begin enforcement as of that effective date.… Continue Reading
The Health Information Privacy page of the U.S. Department of Health and Human Services (HHS) website has formally announced that regulations implementing the privacy and security provisions of the Health Information Technology for Economic and Clinical Health (HITECH) Act will soon be published (along with a comment period) relating to (1) business associate liability; (2) new limitations on the sale of protected health information, marketing and fundraising communications; and (3) stronger individual rights to access electronic medical records and restrict the disclosure of certain information. Although this posting is certainly welcome news, from a timing perspective the announcement only indicates that "OCR continues work on a Notice of Proposed Rulemaking (NPRM) regarding these provisions."… Continue Reading
On October 30, 2009 the Federal Trade Commission (FTC) issued a News Release announcing that it is granting industries under the FTC’s jurisdiction an additional 7 months (i.e., until June 1, 2010) to develop and implement their identity theft prevention programs as required under the FTC’s Identify Theft Red Flags Rule. According to the FTC News … Continue Reading
On Friday, October 30, 2009, the U.S. Department of Health and Human Services ("HHS") published an interim final rule and request for comments that implements certain HIPAA enforcement changes made pursuant to the HITECH Act. Consistent with the provisions of the HITECH Act, the new rule amends the HIPAA enforcement regulations applicable to violations of each of HIPAA's Administrative Simplification Rules (i.e., Privacy Rule, Security Rule, Transactions and Code Sets Rules, Standard Unique Identifier for Employers (EIN Rule), and the Standard Unique identifier for Health Care Providers (NPI Rule)) by instituting the below categories of violations and tiered penalty scheme to HIPAA violations that occur on or after February 18, 2009.… Continue Reading
The recently enacted Health Information Technology for Economic and Clinical Health ("HITECH") Act, which amends various aspects of the Health Insurance Portability and Accountability Act of 1996 ("HIPAA"), including the associated Privacy and Security Rules, marks a significant change in how covered entities and their business associates must respond to security breaches under HIPAA.… Continue Reading
Until now, the loss or theft of protected health information rarely resulted in notice to consumers. Very few state data security breach notification laws encompass medical information. The Health Insurance Portability and Accountability Act ("HIPAA") merely required an "accounting" of such events to a patient upon the patient's request.
All that has changed. Congress, in enacting the Health Information Technology for Economic and Clinical Health Act ("HITECH"), imposed breach notification obligations on many of the individuals and business entities that receive, create, or maintain patients' individually identifiable health information. Pursuant to HITECH, on Aug. 17, the Federal Trade Commission ("FTC") issued its Health Breach Notification Rule, governing the breach notification obligations of three new categories of entity: "vendors of personal health records," "PHR related entities" and "third party service providers."… Continue Reading
On July 29, 2009 the Federal Trade Commission (FTC) issued a News Release announcing that it is granting industries under the FTC's jurisdiction an additional 3 months to develop and implement their identity theft prevention programs as required under the FTC's Identify Theft Red Flags Rule. Additionally, the FTC staff will "redouble" its education efforts and ease compliance by providing additional resources and guidance to clarify whether businesses are covered by the Rule and what they must do to comply. By extending the enforcement date of the Rule until November 1, 2009, the FTC intends to give creditors and financial institutions more time to review the forthcoming guidance and to develop and implement written Identity Theft Prevention Programs. The announcement of the extension is also available at www.ftc.gov.… Continue Reading
On February 17, 2009, President Obama signed into law H.R. 1, the American Recovery and Reinvestment Act (the "ARRA"). The sweeping $790 billion economic stimulus package includes a number of health care policy provisions. Reed Smith's Health Care Memorandum summarizes the major health policy provisions of the Act.… Continue Reading
On Feb. 17, 2009, President Obama signed into law H.R. 1, the American Recovery and Reinvestment Act (the "ARRA").1 This memorandum outlines significant changes and additions to the landscape of federal privacy and security law set forth in Subtitle D of the ARRA. In general, the privacy and security portions of the ARRA become effective 12 months after the enactment of the ARRA, which is approximately February 2010. It is also important to note that the ARRA directs the Secretary of the U.S. Department of Health & Human Services ("HHS") to amend the HIPAA Privacy and Security Rules to implement the legislative changes. As such, the effective dates associated with the rulemaking process will vary.… Continue Reading
On Aug. 19, 2008, the Centers for Medicare & Medicaid Services ("CMS") published a final rule to implement the Fiscal Year 2009 Hospital Inpatient Prospective Payment System (the "2009 IPPS final rule"). 73 Fed. Reg 48433. The IPPS final rule includes significant changes to the federal Physician Self-Referral Law, or "Stark Law," regulations.… Continue Reading
On Aug. 9, 2008, the Pennsylvania Department of Public Welfare ("DPW") published its proposed regulations for assisted living facilities operating within the Commonwealth. The proposed regulations were drafted in response to the Pennsylvania General Assembly's enactment of Act 56 on July 25, 2007.… Continue Reading