Privacy & Information Security Law Blog

On June 20, 2024, the U.S. District Court for the Northern District of Texas Fort Worth Division ruled that guidance issued by the U.S. Department of Health and Human Services (“HHS”) relating to online tracking technologies exceeded HHS’ authority and ordered that it be vacated. 

On April 12, 2023, the U.S. Department of Health and Human Services (“HHS”) issued a Notice of Proposed Rulemaking (“NPRM”) to modify protections under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) to strengthen reproductive health care privacy.

On December 1, 2022, the Office for Civil Rights at the U.S. Department of Health and Human Services (“HHS”) released a Bulletin on the obligations of HIPAA covered entities and business associates under the HIPAA Privacy, Security, and Breach Notification Rules when using online tracking technologies. 

On September 27, 2022, California Governor Gavin Newsom signed into law a pair of bills designed to prevent medical information and other data held by California entities from being used in out-of-state abortion prosecutions. 

On July 8, 2022, President Biden issued an Executive Order titled, “Protecting Access to Reproductive Health Care Services,” in response to the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization that overturned Roe v. Wade. The Executive Order aims, in part, to “ [p]rotect[] the privacy of patients and their access to accurate information” regarding reproductive health care services. It directs the Department of Health and Human Services (“HHS”) and the Federal Trade Commission to take certain steps to address the potential threat to patient privacy caused by the transfer and sale of sensitive health-related data, and by digital surveillance related to reproductive health care services from fraudulent schemes or deceptive practices.

On June 29, 2022, the U.S. Department of Health and Human Services (“HHS”) issued two guidance documents to “help protect patients seeking reproductive health care, as well as their providers” following the Supreme Court’s decision in Dobbs vs. Jackson Women’s Health Organization. These guidance documents address the legal protections for individuals’ protected health information (“PHI”) relating to abortion and other reproductive health care, as well as how individuals can protect their medical information on personal devices, menstruation tracking apps and other health-related apps.

On June 13, 2022, the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) released guidance to help covered entities understand how they can use remote communication technologies for audio-only telehealth in compliance with the HIPAA Privacy and Security Rules (the “Guidance”). Specifically, the Guidance clarifies how audio-only telehealth can be conducted after OCR’s Notification of Enforcement Discretion for Telehealth (the “Telehealth Notification”), put in place during the COVID-19 pandemic, is no longer in effect.

On September 30, 2021, the U.S. Department of Health and Human Services’ (“HHS”) Office for Civil Rights (“OCR”) issued guidance regarding when the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy Rule applies to disclosures and requests for information about a person’s COVID-19 vaccination status.

The United States Court of Appeals for the Fifth Circuit recently vacated a $4.3 million civil monetary penalty imposed by the Department of Health and Human Services’ Office for Civil Rights (“OCR”) in 2017 against the University of Texas M.D. Anderson Cancer Center (“MD Anderson”). The Court held that OCR’s civil monetary penalty for alleged violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy Rule and HIPAA Security Rule was “arbitrary, capricious, and otherwise unlawful.”

On June 11, 2020, the California Senate amended AB-713 to the California Consumer Privacy Act of 2018 (“CCPA”). The Senate’s recent amendments impose new contractual obligations on the use or sale of de-identified information and modify the exemption from the CCPA for information used for public health purposes. The California Assembly had originally passed AB-713 in 2019 to (1) explicitly carve out from coverage by the CCPA information de-identified pursuant to the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy Rule, and (2) expand the CCPA exemption for information used for research purposes. AB-713 is intended to “preserv[e] access to information needed to conduct important health-related research that will benefit Californians.” The revised version of AB-713 containing the Senate’s recent amendments has not yet passed either house of the California legislature.

The Office for Civil Rights (“OCR”) at the U.S. Department of Health and Human Services (“HHS”) issued a Bulletin on sharing and protecting patients’ protected health information (“PHI”) in compliance with the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) during the COVID-19 national emergency. The Bulletin emphasizes that the HIPAA Privacy Rule is still in effect during this national emergency, but that HIPAA-covered entities may use or disclose patients’ PHI when necessary to treat a patient, to protect the nation’s public health and for other critical purposes.

The District Court for the District of Columbia recently invalidated certain Department of Health and Human Services (“HHS”) rules regarding an individual’s access to their protected health information (“PHI”). The Court held that: (1) individuals can only direct their electronic PHI to third parties (and not hard copy PHI); and (2) the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Omnibus Rule provisions regarding the caps on fees that HIPAA-covered entities may charge for such requests did not follow relevant administrative law procedures.

On November 7, 2019, the Office for Civil Rights (“OCR”) of the U.S. Department of Health and Human Services (“HHS”) announced a $1.6 million civil penalty imposed against the Texas Health and Human Services Commission (“TX HHSC”), a state agency, for violations of HIPAA Privacy and Security Rules in connection with the unauthorized disclosure of electronic protected health information (“ePHI”). The ePHI breach – which exposed names, addresses, Social Security numbers, and treatment information of at least 6,617 individuals – was first reported to OCR on June 11, 2015, by Texas’s Department of Aging and Disability Services (“DADS”).

On July 11, 2019, Washington Attorney General Bob Ferguson announced that his office had entered into a consent decree and $10 million settlement with Premera Blue Cross (“Premera”) that stems from a 2014-2015 breach that affected more than 11 million individuals. The settlement, which includes a payment of roughly $5.4 million to Washington state and $4.6 million to a coalition of 29 other state Attorneys General (the “Multistate AGs”), is one of the largest ever for a breach involving protected health information (“PHI”) and comes just one month after another notable HIPAA settlement involving a similar coalition of state AGs.

On May 6, 2019, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) announced that it had entered into a resolution agreement and $3 million settlement with Touchstone Medical Imaging (“Touchstone”). The settlement is the first OCR HIPAA enforcement action in 2019, following an all-time record year of HIPAA enforcement in 2018.

On October 30, 2018, ATA Consulting LLC (doing business as Best Medical Transcription) agreed to a $200,000 settlement with the New Jersey Attorney General resulting from a server misconfiguration that allowed private medical records to be posted publicly online. The fine was suspended to $31,000 based on the company’s financial condition. Read the settlement.

Recently, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) entered into a resolution agreement and record settlement of $16 million with Anthem, Inc. (“Anthem”) following Anthem’s 2015 data breach. That breach, affecting approximately 79 million individuals, was the largest breach of protected health information (“PHI”) in history.

In its most recent cybersecurity newsletter, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) provided guidance regarding identifying vulnerabilities and mitigating the associated risks of software used to process electronic protected health information (“ePHI”). The guidance, along with additional resources identified by OCR, are outlined below:

The Department of Health and Human Services (“HHS”) recently published two advance notices of proposed rulemaking that address the accounting of disclosures and the potential distribution of civil monetary penalties to affected individuals.

On October 3, 2017, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) issued an announcement clarifying when protected health information (“PHI”) can be shared with family, friends and others. This announcement, prompted by the recent mass shooting in Las Vegas, outlines the purposes for which PHI can be disclosed to these parties pursuant to HIPAA and the conditions that apply, which are summarized below:

On September 7, 2017, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) issued an announcement containing disaster preparedness and recovery guidance in advance of Hurricane Irma. The announcement follows a bulletin issued in late August during Hurricane Harvey that addressed how protected health information (“PHI”) can be shared during emergencies. Together, these communications underscore key privacy and security issues for entities covered by HIPAA to help them protect individuals’ health information before, during and after emergency situations.

On May 10, 2017, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) announced a $2.4 million civil monetary penalty against Memorial Hermann Health System (“MHHS”) for alleged violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy Rule. 

On February 16, 2017, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) entered into a resolution agreement with Memorial Healthcare System (“Memorial”) that emphasized the importance of audit controls in preventing breaches of protected health information (“PHI”). The $5.5 million settlement with Memorial is the fourth enforcement action taken by OCR in 2017, and matches the largest civil monetary ever imposed against a single covered entity.

On February 1, 2017, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) announced a $3.2 million civil monetary penalty against Children’s Medical Center of Dallas (“Children’s”) for alleged ongoing violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy and Security Rules, following two consecutive breaches of patient electronic protected health information (“ePHI”). This is the third enforcement action taken by OCR in 2017, following the respective actions taken against MAPFRE Life Insurance of Puerto Rico and Presence Health earlier in January.

On November 22, 2016, the Department of Health and Human Services (“HHS”)  announced a $650,000 settlement with University of Massachusetts Amherst (“UMass”), resulting from alleged violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy and Security Rules. 

Recently, Aegerion Pharmaceuticals announced that it will enter into several settlements and plead guilty to two misdemeanors in connection with alleged violations of HIPAA, drug marketing regulations and securities laws. The criminal charges stem from the company’s marketing of a cholesterol drug called Juxtapid. Aegerion allegedly failed to comply with risk evaluation and management strategies and marketed Juxtapid (which is labeled with a warning about liver toxicity) without proper directions for use. 

The U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) recently announced resolution agreements with Raleigh Orthopaedic Clinic, P.A., (“Raleigh Orthopaedic”) and New York-Presbyterian Hospital (“NYP”) for HIPAA Privacy Rule violations.

On March 16, 2016, and March 17, 2016, respectively, the Department of Health and Human Services (“HHS”) announced resolution agreements with North Memorial Health Care of Minnesota (“North Memorial”) and The Feinstein Institute for Medical Research (“Feinstein Institute”) over potential violations of the HIPAA Privacy Rule.

On March 21, 2016, the Department of Health and Human Services’ Office for Civil Rights (“OCR”) announced that it has commenced Phase 2 of the HIPAA Audit Program. Phase 1 of the HIPAA Audit Program ran from 2011-2012 and produced several notable findings, including that two-thirds of covered entities had not performed a risk assessment as required by the HIPAA Security Rule.

On February 3, 2016, the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) announced that an Administrative Law Judge (“ALJ”) ruled that Lincare, Inc. (“Lincare”) violated the HIPAA Privacy Rule and ordered the company to pay $239,800 to OCR.

On July 10, 2015, the United States House of Representatives passed the 21st Century Cures Act (the “Act”), which is intended to ease restrictions on the use and disclosure of protected health information (“PHI”) for research purposes.

The Department of Health and Human Services (“HHS”) recently announced a resolution agreement and $125,000 settlement with Cornell Prescription Pharmacy (“Cornell”) in connection with the disposal of prescription records in an unsecured dumpster on Cornell’s premises. After receiving a report from a Denver television station regarding Cornell’s disposal practices, the HHS’ Office for Civil Rights (“OCR”) investigated Cornell and found several HIPAA Privacy Rule violations, including that Cornell had failed to:

On June 23, 2014, the Department of Health and Human Services (“HHS”) announced a resolution agreement and $800,000 settlement with Parkview Health System, Inc. (“Parkview”) following a complaint involving patient medical records that were dumped by Parkview employees and left unattended on a physician’s driveway.

On June 12, 2014, Connecticut Governor Dannel Malloy signed a bill into law that may require retailers to modify their existing Health Insurance Portability and Accountability Act (“HIPAA”) authorizations for pharmacy reward programs. The law, which will become effective on July 1, 2014, obligates retailers to provide consumers with a “plain language summary of the terms and conditions” of their pharmacy reward programs before the consumers may enroll. It also requires retailers to include specific content in their authorization forms that are required pursuant to the HIPAA. If the consumer is required to sign a HIPAA authorization to participate in a pharmacy reward program, the authorization must include the following items “adjacent to the point where the HIPAA authorization form is to be signed:”

On May 7, 2014, the Department of Health and Human Services (“HHS”) announced that NewYork-Presbyterian Hospital (“NYP”) and Columbia University (“CU”) agreed to collectively pay $4.8 million in the largest HIPAA settlement to date, to settle charges that they potentially violated the HIPAA Privacy and Security Rules.

On April 23, 2014, the Department of Health and Human Services (“HHS”) announced settlements with two health care companies stemming from allegations of inadequate information security practices in the wake of investigations involving stolen laptop computers. Concentra Health Services (“Concentra”) and QCA Health Plan Inc. (“QCA”) will collectively pay nearly $2 million to settle the claims.

The Department of Health and Human Services’ Office for Civil Rights (“OCR”) recently announced that it intends to survey up to 1,200 covered entities and business associates to determine their suitability for a more fulsome HIPAA compliance audit. In a notice published in the Federal Register, OCR stated that the survey will collect information such as “number of patient visits or insured lives, use of electronic information, revenue, and business locations” to assess the organizations’ “size, complexity and fitness” for an audit.

On March 7, 2014, the Department of Health and Human Services (“HHS”) announced a resolution agreement and $215,000 settlement with Skagit County, Washington, following a security breach that affected approximately 1,600 individuals.

The Department of Health and Human Services’ Office for Civil Rights (“OCR”) recently released guidance about the use and disclosure of mental health information. The guidance, entitled “HIPAA Privacy Rule and Sharing Information Related to Mental Health,” contains thirteen questions and answers that address the following topics:

Today, September 23, 2013, marks the deadline for compliance with the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Omnibus Rule that was issued in January 2013. Covered entities, business associates and subcontractors that access, use or disclose protected health information (“PHI”) will need to take the following actions:

This week, the Department of Health and Human Services’ Office for Civil Rights (“OCR”), in conjunction with the Office of the National Coordinator for Health Information Technology, released model Notices of Privacy Practices. The notices, which have been developed for use by health care providers and health plans, come in different formats:

• an 8-page booklet;
• a 5-page layered notice that summarizes key details on the first page and includes the full content of the booklet on the remaining four pages;
• a 5-page condensed version of the 8-page booklet; and
• a 6-page text-only version of the booklet.

On July 11, 2013, the Department of Health and Human Services (“HHS”) announced a resolution agreement and $1.7 million settlement with WellPoint Inc. following a security breach that affected over 600,000 individuals.

On June 13, 2013, the Department of Health and Human Services (“HHS”) announced a resolution agreement and $275,000 settlement with Shasta Regional Medical Center (“Shasta”) that pertained to impermissible disclosures of protected health information (“PHI”) by Shasta officials to the media, as well as to Shasta’s entire workforce.

On April 9, 2013, the United States Court of Appeals for the Eleventh Circuit held that the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) preempted a Florida law regarding the disclosure of patient records by nursing homes. The law required nursing homes in Florida to provide the medical records of a deceased nursing home resident to the “spouse, guardian, surrogate, proxy, or attorney in fact,” including “medical and psychiatric records and any records concerning the care and treatment of the resident performed by the facility, except progress notes and consultation report sections of a psychiatric nature.”

On January 17, 2013, the U.S. Department of Health and Human Services issued a final omnibus rule modifying prior regulations enacted pursuant to the Health Insurance Portability and Accountability Act of 1996. Among the key changes that will come into effect this September is the addition of a provision that dramatically increases the number of organizations directly subject to the HIPAA Privacy, Security, Breach Notification and Enforcement Rules. In an article published in the March/April issue of Storage & Destruction Business Magazine, Lisa J. Sotto, partner and head of the ...

The wait is over. On January 17, 2013, the Department of Health and Human Services’ (“HHS’”) Office for Civil Rights (“OCR”) released its long-anticipated megarule (“Omnibus Rule”) amending the HIPAA Privacy, Security, Breach Notification and Enforcement Rules. These amendments implement and expand on the requirements of the Health Information Technology for Economic and Clinical Health (“HITECH”) Act and the Genetic Information Nondiscrimination Act of 2008. The Omnibus Rule is effective March 26, 2013, and compliance is required with respect to most provisions no later than September 23, 2013. Coming into compliance will require significant effort and attention by covered entities and business associates alike. Below we highlight some of the more significant aspects of the Omnibus Rule and provide critical compliance tips.

On January 17, 2013, the Department of Health and Human Services (“HHS”) issued a Final Omnibus Rule modifying the Privacy, Security and Enforcement Rules promulgated pursuant to the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) as well as the Breach Notification Rule promulgated pursuant to the Health Information Technology for Economic and Clinical Health Act (the “HITECH” Act) enacted in 2009. The Final Rule comes two and a half years after the proposed rule was published in July 2010.

On January 7, 2013, Massachusetts Attorney General Martha Coakley announced that several Massachusetts medical practices have agreed to a consent judgment and $140,000 payment to settle charges they improperly disposed of medical information. The defendants, which include several pathology practices and a firm that provided medical billing services to those practices, were accused of dumping hard copy medical records at the Georgetown Transfer Station, a waste management facility open to the public. The records allegedly contained the names, Social Security numbers and medical diagnoses of approximately 67,000 individuals. The illegal dumping allegations were publicized in a Boston Globe article after a photographer for the newspaper discovered medical records at the facility while he was disposing of his own trash.

In an interview with Marianne Kolbasuk McGee of HealthcareInfoSecurity, Lisa J. Sotto, partner and head of the Global Privacy and Data Security practice at Hunton & Williams LLP, discusses the measures health care organizations should take to prepare for the issuance of the upcoming HIPAA Omnibus Rule. In March 2012, the Department of Health and Human Services (“HHS”) sent its final Omnibus Rule modifying the HIPAA Privacy, Security and Enforcement Rules to the White House Office of Management and Budget. In the interview, Sotto outlines her predictions of the content of the Omnibus Rule, including “modifications to the HIPAA privacy, security and enforcement rules” and “a final version of the HIPAA breach notification rule.”

On November 26, 2012, the Department of Health and Human Services’ Office for Civil Rights (“OCR”) published guidance on the two methods for de-identifying protected health information (“PHI”) in accordance with the HIPAA Privacy Rule. The guidance, which was required by the Health Information Technology for Clinical and Economic Health (“HITECH”) Act, has been developed over several years by OCR in collaboration with healthcare entities and other industry experts and builds upon the discussions from a workshop on de-identification that took place in March 2010.

The Department of Health and Human Services Office for Civil Rights (“OCR”) has posted an audit protocol on its website to provide information about the procedures currently being used by OCR as part of its new audit program.

The protocol is presented in a sortable table format listing the applicable sections of the relevant rules and the established performance criteria, key activities and audit procedures associated with each section. The audit protocol for the HIPAA Security Rule also lists whether the implementation specification is required or addressable pursuant to that Rule.

On June 7, 2012, at the annual Safeguarding Health Information: Building Assurance through HIPAA Security Conference hosted in Washington, D.C. by the Department of Health and Human Services Office for Civil Rights (“OCR”) and the National Institute of Standards and Technology (“NIST”), OCR Director Leon Rodriguez said that, given HIPAA’s 15-year history and the substantial technical assistance OCR and NIST have provided covered entities, tolerance for HIPAA non-compliance is “much, much lower” than it has been in the past.

In the past month, the Department of Health and Human Services (“HHS”) sent its final omnibus rule modifying the HIPAA Privacy, Security and Enforcement Rules to the White House Office of Management and Budget (“OMB”) and announced a $100,000 settlement with Phoenix Cardiac Surgery, P.C. for violations of the HIPAA Rules.

On March 13, 2012, the Department of Health and Human Services (“HHS”) announced that it had settled the first case related to the HITECH Act Breach Notification Rule. BlueCross Blue Shield of Tennessee (“BCBS Tennessee”) agreed to pay $1.5 million to settle potential HIPAA violations related to the October 2009 theft of 57 unencrypted hard drives containing protected health information (“PHI”) from a network data closet at a leased facility leased in Chattanooga, Tennessee.

On January 19, 2012, Minnesota Attorney General Lori Swanson announced a lawsuit against Accretive Health, Inc., (“Accretive”) for violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and its implementing regulations, the Minnesota Health Records Act, Minnesota’s debt collection statutes and Minnesota’s consumer protection laws. The suit, which was filed in Federal District Court in Minnesota, alleges that Accretive failed to adequately safeguard patients’ protected health information (“PHI”). This failure contributed to a July 2011 information security breach when an Accretive employee left an unencrypted laptop containing information of approximately 23,500 patients in a rental car. The laptop was stolen and has not yet been recovered.

Several health care industry groups requested that the Department of Health and Human Services (“HHS”) either remove or significantly revise a proposed “access report” requirement in its recent notice of proposed rulemaking (the “Proposed Rule”) for the accounting of disclosures of protected health information (“PHI”).  As we reported in May, HHS issued the Proposed Rule that revises existing HIPAA Privacy Rule provisions regarding accounting of disclosures and gives individuals a new right to obtain an “access report” that would list the specific persons who have accessed a patient’s PHI, and describe any actions taken by those persons with respect to the PHI (e.g., create, modify, access or delete).

On July 28, 2011, the International Association of Privacy Professionals (“IAPP”) hosted a webinar that addressed the upcoming audit program of the Department of Health and Human Services Office of Civil Rights (“OCR”).  Susan McAndrew, the Deputy Director for Health Information Privacy at OCR, provided an overview of the audit program, noting that it stemmed from Section 13411 of the Health Information Technology for Economic and Clinical Health (“HITECH”) Act.  That section of the HITECH Act authorized the Secretary of the Health and Human Services to “provide for periodic audits to ensure that covered entities and business associates” comply with the requirements of the HIPAA Privacy and Security Rules.

Last month, Texas Governor Rick Perry signed a health privacy bill into law that imposes new obligations exceeding the requirements in the HIPAA Privacy Rule.  The law, which will become effective on September 1, 2012, incorporates the expanded definition of the term “covered entity” in Texas’s existing health privacy law and could have a broad impact on many non-HIPAA covered entities.

On June 7, 2011, the Department of Health and Human Services (“HHS”) announced a resolution agreement and $865,500 settlement with the University of California at Los Angeles Health System (“UCLA Health System”) for violations of the HIPAA Privacy and Security Rules.  UCLA Health System employees were accused of violating the Privacy Rule by improperly accessing the protected health information (“PHI”) of patients, including several high-profile celebrities who filed complaints with HHS.  A subsequent investigation by HHS’s Office for Civil Rights (“OCR”) revealed that in addition to neglecting to sanction the employees who had improperly accessed patient PHI, UCLA Health System had failed to train its employees on the HIPAA Privacy and Security Rules or implement security measures to “reduce the risks of impermissible access to electronic protected health information by unauthorized users to a reasonable and appropriate level.”

On May 27, 2011, the Department of Health and Human Services (“HHS”) issued a notice of proposed rulemaking regarding the HIPAA Privacy Rule provision that requires covered entities to provide an accounting of disclosures of protected health information (“PHI”) to individuals upon request.  The proposed rule revises existing HIPAA Privacy Rule provisions regarding an accounting of disclosures and also gives individuals a new right to obtain an “access report” about which specific individuals have accessed electronic PHI in a designated record set.  The proposed rule also requires covered entities to modify their privacy notices to include that individuals have the right to obtain an access report from the covered entities.

On March 7, 2011, Arthur Steinberg and the Philadelphia Federation of Teachers Health and Welfare Fund sued CVS Caremark Corporation (“CVS”), alleging that its unauthorized disclosure of protected health information (“PHI”) constituted an unfair trade practice. The complaint claims that CVS, one of the nation’s largest pharmacies, sent letters to physicians that listed their patients’ names, dates of birth and prescribed medications. The letters encouraged the physicians to prescribe drugs made by pharmaceutical manufacturers, who paid CVS to send ...

On February 24, 2011, the Department of Health and Human Services Office of Civil Rights (“OCR”) announced a $1,000,000 Resolution Agreement with the General Hospital Corporation and Massachusetts General Physicians Organization Inc. (“Mass General”) that stemmed from the loss of protected health information (“PHI”) of 192 patients.  A Mass General employee had left hard-copy records containing PHI on the subway in March 2009.  The records originated from Mass General’s Infectious Disease Associates outpatient practice and included sensitive records discussing patients’ treatments for HIV/AIDS.  After receiving a complaint from an affected patient, OCR conducted an investigation that demonstrated that Mass General had “failed to implement reasonable, appropriate safeguards to protect the privacy of PHI when removed from Mass General’s premises and impermissibly disclosed PHI potentially violating provisions of the HIPAA Privacy Rule.”

On February 22, 2011, the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) imposed its first civil money penalty for an entity’s violation of HIPAA’s Privacy Rule.  In its Notice of Final Determination, OCR concluded that Cignet Health withheld patient records despite requests for their disclosure.  Of the $4.3 million penalty, $1.3 million was levied for denying patients access to their own medical records, while an additional $3 million was imposed due to Cignet’s failure to cooperate with OCR’s investigation as required by the Privacy Rule.  Increased penalty amounts were authorized by Section 13410(d) of the Health Information Technology for Economic and Clinical Health Act (the “HITECH” Act).

The Department of Health and Human Services (“HHS”) received numerous comments on its proposed modifications to the Health Insurance Portability and Accountability Act Privacy, Security and Enforcement Rules, which were issued on July 8, 2010.  Some highlights from the comments are outlined below.

Enforcement Rule

The American Hospital Association (“AHA”) suggested that HHS should continue to require the Secretary of HHS to attempt to resolve a complaint or compliance review through informal means, instead of making the informal resolution process optional.  According to the AHA, making “resolution via informal means optional, regardless of the perceived level of culpability of a particular entity” would not be appropriate or effective.  The Coalition for Patient Privacy, on the other hand, recommended stricter enforcement so that “the only category of violators that should not be penalized with fines are those who despite due diligence could not discover the violation, who reported the violation immediately when discovered, and fully corrected the problems within 30 days of discovery.”

On July 8, 2010, the Department of Health and Human Services ("HHS") issued a notice of proposed rulemaking to modify the Privacy, Security and Enforcement Rules promulgated pursuant to the Health Insurance Portability and Accountability Act of 1996.  The modifications implement changes made by the Health Information Technology for Economic and Clinical Health Act (the “HITECH” Act) enacted in 2009.

David Holtzman, a health information privacy specialist at the Office for Civil Rights (“OCR”) within the Department of Health and Human Services (“HHS”), stated at a health privacy conference on May 11, 2010, that OCR has been “vigorously” enforcing the Security Rule, which was promulgated pursuant to the Health Insurance Portability and Accountability Act (“HIPAA”).  Prior to 2009, HHS divided civil enforcement responsibility for HIPAA between OCR, which enforced the HIPAA Privacy Rule, and the Centers for Medicare and Medicaid Services (“CMS”), which enforced the HIPAA Security Rule.  In July 2009, the Secretary of HHS delegated authority to enforce the HIPAA Security Rule to OCR to “facilitate improvements by eliminating duplication and increasing efficiency.”

We understand that yesterday Adam H. Greene (Office of the General Counsel, Civil Rights Division, U.S. Department of Health & Human Services), speaking at the ABA’s 11th Annual Conference on Emerging Issues in Healthcare Law, indicated that enforcement of the business associate provisions of the Health Information Technology for Economic and Clinical Health Act (the “HITECH Act”), which became effective on February 17, 2010, will be delayed until final rules addressing those provisions are published.  The HITECH Act’s business associate provisions require business associates to implement the information security safeguards specified by the HIPAA Security Rule, and comply with certain requirements of the HIPAA Privacy Rule.  Similarly, the HITECH Act requires covered entities to provide in their business associate agreements that all of the HITECH Act’s security requirements applicable to covered entities are also applicable to business associates.

In a move that portends increased enforcement of the Health Insurance Portability and Accountability Act (“HIPAA”) Privacy Rule, the Department of Health and Human Services (“HHS”) has created two new positions on its health information privacy enforcement team.  According to the job listings, the new Health Information Privacy Specialists at the HHS Office for Civil Rights (“OCR”) will be responsible for “reviewing, analyzing, implementing, promoting, or improving proposed or existing programs or policies needed to implement OCR’s authority for ensuring ...

Two California medical privacy laws became effective on January 1, 2009.  The laws, A.B. 211 and S.B. 541, create new obligations for health care providers and facilities in California to protect against unlawful or unauthorized access to patient medical information.  In contrast, other medical privacy regulations, including the Privacy Rule promulgated under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), focus only on the unauthorized use or disclosure of protected health information.