HHS issues proposed rule on accounting of PHI disclosures

Posted on June 1, 2011 by Steve Fox and Vadim Schick

On May 31, 2011, HHS released the proposed rule on accounting for dislosures of protected health information (PHI), which modified the HIPAA Privacy Rule pursuant to the HITECH Act. This proposed rule would give individuals the right to get a report on who has electronically accessed their PHI. Via HHS press release:

'This proposed rule represents an important step in our continued efforts to promote accountability across the health care system, ensuring that providers properly safeguard private health information,' said OCR Director Georgina Verdugo. 'We need to protect peoples’ rights so that they know how their health information has been used or disclosed.'

People would obtain this information by requesting an access report, which would document the particular persons who electronically accessed and viewed their protected health information. Although covered entities are currently required by the HIPAA Security Rule to track access to electronic protected health information, they are not required to share this information with people.

The proposed rule requires an accounting of more detailed information for certain disclosures that are most likely to affect a person’s rights or interests. The proposed changes to the accounting requirements provide information of value to individuals while placing a reasonable burden on covered entities and business associates.

You can view and download the proposed rule by clicking here.

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Updates to privacy and security regulations expected soon

Posted on May 16, 2011 by Steve Fox and Vadim Schick

According to Healthcareinfosecurity.com, the Office of Civil Rights (OCR) is still working on the final rule regarding the updates to HIPAA and the related HIPAA Privacy and Security Rules mandated by the HITECH Act. Susan McAndrew, deputy director for health information privacy at OCR, stated at a conference in Washington, DC, that such changes will be contained in one omnibus regulation and is expected to be published in a matter of months, if not weeks.

Such omnibus regulation will cover:

  • HITECH Act-mandated modifications to the HIPAA privacy, security and enforcement rules. These changes, for example, formalize higher penalties for HIPAA violations and make it clear that business associates must comply with HIPAA. Last December, HHS had indicated in its semi-annual regulatory agenda that the final HIPAA modifications, many of which were issued in preliminary form last year, would be completed by March.
     
  • The breach notification rule. An interim final version is already in effect. OCR yanked a proposed final version of the rule last year for further consideration. Some observers speculated that the office may be reconsidering the controversial "harm standard" in the interim final version of the rule, which enables organizations to conduct a risk assessment to determine whether a security incident represents a significant risk of harm and thus merits reporting.
     
  • Privacy provisions under the Genetic Information Nondiscrimination Act. These provisions will formalize that using genetic information for insurance underwriting purposes is a privacy violation as well as a non-discrimination violation, McAndrew said.

 

Ms. McAndrew also indicated that "a notice of proposed rulemaking revealing a proposal for accounting for disclosures of information in electronic health records "probably" would be issued before the omnibus set of final regulations. Once that notice is issued, OCR will accept comments before issuing a proposed rule."

"HITECH Mandated Regs Still in Works," Healthcareinfosecurity.com (May 11, 2011).

 
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Cignet Health fined $4.3 million for HIPAA Privacy Rule violation

Posted on February 22, 2011 by Steve Fox and Vadim Schick

Cignet Health, a Maryland health plan and a HIPAA covered entity, has been fined $4.3 million for failing to produce health records upon request to 41 patients, and for failing to cooperate with OCR with the agency's investigation.  This is the very first civil money penalty (CMP) issued by HHS under the HIPAA Privacy Rule.

Via HHS Press Release:

In a Notice of Proposed Determination issued Oct. 20, 2010, OCR found that Cignet violated 41 patients’ rights by denying them access to their medical records when requested between September 2008 and October 2009. These patients individually filed complaints with OCR, initiating investigations of each complaint. The HIPAA Privacy Rule requires that a covered entity provide a patient with a copy of their medical records within 30 (and no later than 60) days of the patient’s request. The CMP for these violations is $1.3 million.

During the investigations, Cignet refused to respond to OCR’s demands to produce the records. Additionally, Cignet failed to cooperate with OCR’s investigations of the complaints and produce the records in response to OCR’s subpoena. OCR filed a petition to enforce its subpoena in United States District Court and obtained a default judgment against Cignet on March 30, 2010. On April 7, 2010, Cignet produced the medical records to OCR, but otherwise made no efforts to resolve the complaints through informal means.

 

 OCR also found that Cignet failed to cooperate with OCR’s investigations on a continuing daily basis from March 17, 2009, to April 7, 2010, and that the failure to cooperate was due to Cignet’s willful neglect to comply with the Privacy Rule. Covered entities are required under law to cooperate with the Department’s investigations. The CMP for these violations is $3 million.

“Covered entities and business associates must uphold their responsibility to provide patients with access to their medical records, and adhere closely to all of HIPAA’s requirements,” said OCR Director Georgina Verdugo. “The U.S. Department of Health and Human Services will continue to investigate and take action against those organizations that knowingly disregard their obligations under these rules.”

Individuals who believe that a covered entity has violated their (or someone else’s) health information privacy rights or committed another violation of the HIPAA Privacy or Security Rule may file a complaint with OCR at http://www.hhs.gov/ocr/privacy/hipaa/complaints/index.html.

A copy of the Notice of Proposed Determination and Notice of Final Determination can be found at http://www.hhs.gov/ocr/privacy. Additional information about OCR’s enforcement activities can be found at http://www.hhs.gov/ocr.

 
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Rite Aid settles FTC and OCR privacy charges

Posted on July 29, 2010 by Steve Fox and Vadim Schick

The Rite Aid Corporation, the third largest pharmacy chain in the United States, reached a major settlement with both the Federal Trade Commission (FTC) and HHS's Office of Civil Rights (OCR) regarding charges that Rite Aid violated federal privacy and security laws and regulations by failing to keep its customers' and employees' data safe. 

Rite Aid employees were reported to discard prescriptions and pill bottles containing sensitive patient data into the dumpsters behind various Rite Aid pharmacies, which were easily accessible to the public.  Such practices violate the HIPAA Privacy Rule, which requires covered entities to safeguard the privacy of patient information, even when such information is being destroyed.  Rite Aid's actions may also violate the company's own promises to their customers regarding keeping their health information private and secure (this broken promise being the basis for FTC's charges).

 

In addition, OCR and FTC found that Rite Aid:

  • failed to implement adequate policies and procedures to appropriately safeguard patient information during the disposal process;
  • failed to adequately train employees on how to dispose of such information properly;
  • failed to employ a reasonable process for discovering and remedying risks to personal information; and
  • did not maintain a sanctions policy for members of its workforce who failed to properly dispose of patient information.

Pursuant to their settlement with HHS, Rite Aid agreed to pay HHS a cool $1 million and agreed to implement a strong corrective action program (lasting 3 years) which includes:

  • Revising and distributing its policies and procedures regarding disposal of protected health information and sanctioning workers who do not follow them;
  • Training workforce members on these new requirements;
  • Conducting internal monitoring; and
  • Engaging a qualified, independent third-party assessor to conduct compliance reviews and render reports to HHS.

Finally, Rite Aid has also agreed to external independent assessments of its pharmacy stores’ compliance with the FTC consent order, which will be in place for 20 years.

FTC and OCR have previously filed charges against CVS Caremark, another major pharmacy chain which was reported to engage in similar violations to Rite Aid's.  

The current economic conditions require most organizations to do more with less. The unfortunate end result is that long term projects, such as major privacy and security compliance reviews and overhauls get postponed and overlooked.  Rite Aid and CVS cases should remind covered entities and other organizations responsible for keeping patient information safe that neglect or procrastination with regard to privacy policies and practices can lead to major fines, PR embarrassments and excessive compliance and legal costs. 

It is also key to remember that your organization must comply with its own privacy policies and procedures -- otherwise, FTC can charge your organization for "false promises," as was the case with Rite Aid.  In order to comply with such policies, however, your organization must train the staff about the critical importance of privacy.  Without such training, all the policies and procedures will be rendered entirely ineffective.

You can read the full OCR press release by clicking here.

You can read the full FTC press release by clicking here.
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OCR adds investigators to boost security rule enforcement

Posted on May 13, 2010 by Steve Fox and Vadim Schick

According to Health Data Management, Susan McAndrew, deputy director for privacy at the Department of Health and Human Services’ Office for Civil Rights (OCR) announced at a recent conference that OCR added investigators to 10 regional offices in order to boost enforcement of HIPAA privacy and security rules. 

On August 3, 2009, HHS Secretary Kathleen Sebelius transferred the responsibility for HIPAA Security Rule enforcement from CMS to OCR, which is now tasked with enforcement of both the HIPAA Security Rule and the HIPAA Privacy Rule.

While the transition from CMS to OCR "took longer than expected," Ms. McAndrew believes that OCR is finally in a position to increase enforcement efforts in order to realize the privacy and security initiatives enacted last year pursuant to the HITECH Act.

We’re hoping to move security to the forefront and make it a real partner with privacy in our enforcement... [and] that with additional feet on the ground, we’ll be able to do many more security cases as the year moves forward.

"OCR Boosting Security Enforcement," Health Data Management (May 12, 2010).

 

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OCR may delay enforcement of business associate provisions in the HITECH Act

Posted on February 23, 2010 by Steve Fox and Vadim Schick

Pursuant to the HITECH Act, on February 17, 2010, business associates of covered entities became subject to the HIPAA Privacy and Security Rules, including provisions regarding implementation of various safeguards to secure protected health information.  As Steve Fox pointed out in a recent report on the subject by the Pittsburgh Business Journal, it is highly unlikely that most companies are ready to comply with these dramatic changes.

However, according to Hunton & Williams's privacy blog, Adam Greene of the HHS Office of Civil Rights (OCR) stated at an ABA conference on February 18, 2010, that OCR will delay enforcement of this provision of the HITECH Act until the relevant regulations are finalized.  OCR itself did not publish a press release on the subject, and we were unable to reach Mr. Greene for comment.

Regardless of OCR's intent to enforce compliance, the business associate provisions in the HITECH Act went into effect last week.  We would strongly encourage all covered entities and business associates to take all necessary actions to comply with the new law.

"Privacy policies over electronic health records expand reach," Pittsburgh Business Journal (February 19, 2010).

"HHS Delays Enforcement of HITECH Act Business Associate Provisions," Privacy & Information Security Law Blog (February 19, 2010).

 

 

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In the news: Privacy breaches and de-identification

Posted on January 11, 2010 by Steve Fox and Vadim Schick
  • According to LA Weekly, Huping Zhou, a former employee at the UCLA Healthcare System, pleaded guilty to federal charges of breaches of patient privacy.  Zhou, 48, accessed the UCLA patient records system 323 times during the three-week period, mostly looking for the files of celebrities, after being let go by the hospital. Names of targeted celebrities have not been revealed.  This case follows a similar breach at UCLA Medical Center, when Lawanda Jackson, a former nurse at the Center, plead guilty to wrongfully accessing information of Britney Spears and Farrah Fawcett.
  • Delaware Online reports about a new unfortunate trend in medical identity theft -- searching for copies of discarded prescriptions:  "In the latest crime trend to hit Delaware, police are reporting that people looking for drugs such as Oxycontin and Vicodin are stalking customers who throw away prescription bags containing paperwork with details about their pills and themselves. They use the personal information to call in prescriptions and charge them to the victims' insurance. Then they turn around and sell the drugs."  According to Bruce DiVincenzo, chief agent of Delaware's Office of Narcotics and Dangerous Drugs:

They're making their own scripts by ordering paper from the Internet," he said. "It's the patient's name that they want, because that person is actively listed as a customer of the pharmacy and will not raise suspicion."

Pharmacies like CVS and Happy Harry's (a subsidiary of Walgreens) take certain precautions to prevent such identity theft, including checking ID's before filling prescriptions and reminding customers to be careful with their receipts and copies of prescriptions.

  • According to Washington Technology, HHS is looking for a contractor to research the effectiveness of "de-identifying" PHI:

Under this new contract, HHS will research re-identifying the data and matching it to a specific individual.

'The contractor shall take one or more HIPAA Privacy Rule de-identified data sets and, using methods and technologies that exclude 'brute force' matching, demonstrate the ability or inability to re-identify the data,' the notice states.

The re-identification must be an accurate and unambiguous match to an individual.

"Former UCLA Health Worker Pleads Guilty To Accessing Celebrities' Medical Records," LA Weekly (January 8, 2010).

"Delaware crime: Trash-picking identity theft targets pharmacy customers," Delaware Online (January 6, 2009).

"HHS wants contractor to test privacy of 'anonymous' data," Washington Technology (January 5, 2010).
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HHS News: Interim Final Regulations on Breach Notification; Regional Office Privacy Advisors

Posted on August 20, 2009 by Steve Fox and Vadim Schick

On August 19, 2009, pursuant to the HITECH Act, the Department of Health and Human Services (HHS) published the interim final regulations regarding breach notification requirements for health care providers and other entities covered by HIPAA. 

According to the HHS press release:

The regulations, developed by the HHS Office for Civil Rights (OCR), require health care providers and other HIPAA covered entities to promptly notify affected individuals of a breach, as well as the HHS Secretary and the media in cases where a breach affects more than 500 individuals. Breaches affecting fewer than 500 individuals will be reported to the HHS Secretary on an annual basis. The regulations also require business associates of covered entities to notify the covered entity of breaches at or by the business associate.

You can find the text of the regulation here.

Stay tuned for more analysis of this important set of regulations on this blog. The interim final regulations are effective 30 days after publication in the Federal Register and include a 60-day public comment period. 

Also, pursuant to Section 13403(a) of the HITECH Act, the HHS Secretary Kathleen Sebelius designated an individual in each regional office of HHS (Regional Office Privacy Advisors) in order "to offer guidance and education to covered entities, business associates, and individuals on their rights and responsibilities related to the HIPAA Privacy and Security Rules."  The names, addresses, and contact information for each of the Regional Managers are listed here, together with a list of the States for which each Regional Manager has responsibility.

"HHS Issues Rule Requiring Individuals Be Notified of Breaches of Their Health Information," HHS Press Release (August 19, 2009).

" Designation of Regional Office Privacy Advisors," HHS Press Release (July 27, 2009).
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Sebelius shifts responsibility for HIPAA Security Rule enforcement to OCR

Posted on August 4, 2009 by Steve Fox and Vadim Schick

HHS Secretary Kathleen Sebelius has delegated the responsibility for administration and enforcement of the HIPAA Security Rule to the Office of Civil Rights, a division of HHS.  Previously, Centers for Medicare and Medicaid Services (CMS), another HHS division, was responsible for Security Rule administration, while OCR was tasked with administering and enforcing the HIPAA Privacy Rule.  Effective immediately, OCR is responsible for administering both Security  Rule and Privacy Rule, as well as all HIT privacy and security related provisions in the HITECH Act.

According to HHS, this move "will eliminate duplication and increase efficiencies in how the department ensures that Americans’ health information privacy is protected."  This transfer of authority is not meant to create any disruption of current procedures.  Consumers may continue to submit HIPAA security complaints using the on-line resource – the Administrative Simplification Enforcement Tool (ASET) -- which can be accessed here. New security complaints may also be sent to the Office for Civil Rights. 

You can find the Federal Register notice here.

"HHS Delegates Authority for the HIPAA Security Rule to Office for Civil Rights," HHS Press Release (August 3, 2009).

 

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