HHS Settlement Follows Enforcement Fine

In a uniquely timed second showing of enforcement authority, the Department of Health and Human Services (HHS) announced on February 24, 2011 a one million dollar settlement with a Massachusetts hospital that allegedly breached patient data.  This settlement announcement comes only days after HHS announced a 4.3 million dollar HIPAA Privacy Rule fine.  The Massachusetts hospital settlement resulted from a hospital employee who took home documents containing sensitive personal information on patients. The employee then lost those documents while commuting to work.  

While the settlement did not include an admission of liability, in addition to the monetary settlement, and submitting to HHS oversight, the hospital must also adopt more stringent privacy practices and retain an independent security and privacy monitor. The investigation of the incident found the hospital failed to implement reasonable and appropriate standards to protect the privacy of patient information removed from the facility.  Under the settlement, the hospital must present new privacy and data security administrative, physical, and technical safeguards policies and procedures for HHS approval. Specifically, these policies and procedures must address the physical removal and transportation of protected health information and encryption of portable storage devices.  Despite a general prohibition on employees physically removing protected health information from the hospital,  HHS permitted an exception when the information is removed by an employee to perform his or her job duties.  Additionally, the hospital must implement training for all employees.  

This settlement, when considered with the 4.3 million dollar fine, likely signals how HHS will approach future enforcement actions.  In light of this, covered entities must seriously examine their privacy and security obligations, including implementing appropriate policies and procedures regarding the safeguarding of information.

 

Data Security, Destruction and Encryption Leads the Way for States in 2010

Less than one month into 2010 the trend to address data security, destruction, and encryption has continued among state lawmakers. Specifically, Florida, Michigan, Kentucky, Kansas, Pennsylvania, and New York all have introduced, reintroduced, or amended legislation of this kind. 

  • The Florida and Michigan laws would amend personal data destruction rules for companies.
  • The New York law would mandate data security and encryption measures.
  • The Kentucky bill would require government agencies to protect all personal data under the Gramm-Leach-Bliley Act.
  • The Michigan bill includes a state version of the Federal Trade Commission's Red Flags Rule and would require creditors in the state to implement programs aimed at spotting “red flags” of possible identity theft and put in place mitigation measures. Michigan is also considering a number of other measures. 
  • The Kansas law would require state agencies to engage in periodic network security reviews.
  • The Pennsylvania bill would require public agencies to notify state residents of a breach of their personal information within seven days of the discovery of the breach.

While 5 states remain without data breach notice bills (Alabama, Kentucky, Mississippi, New Mexico, and South Dakota), Congress is considering legislation, the Data Accountability and Trust Act (DATA) (H.R. 2221), that would preempt all state notification laws and instead establish a national breach notice standard.

As we have previously mentioned, we anticipate data privacy and security legislation and case law to be at the forefront of legal issues in 2010. Employers should begin by reading the Data Security Primer and consider implementing comprehensive data security policies and procedures that would allow them to comply with the various state laws that may impact their business. 

While we have highlighted the main points of each of the proposed laws, a more detailed analysis of the laws put forth in Michigan, Florida, and New York is set forth below. 

Michigan

The new Michigan data destruction bill would ease existing personal data disposal requirements outlined in the state's Identity Theft Protection Act mandating that companies and agencies removing information from a database destroy only “unencrypted, unredacted personal information” and only such personal information related to state residents.

Another bill would require businesses with 50 or more employees that are “engaged in extending credit in the form of covered accounts to residents of this state” to implement and identity theft mitigation programs similar to those required under the federal Fair and Accurate Credit Reporting Act Red Flags Rule.   Companies that have complied with the federal Red Flags Rule would be exempt from the state law.

Michigan is also considering various other measures which would establish an Identity Theft Commission; make technical changes to the law; add misleading a law enforcement or court official about one's identity to the list of violations of the law; and authorize the state attorney general to seek civil fines of up to $10,000 per incident for identity thieves.

Michigan is also considering a bill which would make businesses and agencies that adopt comprehensive data security safeguards to protect personal data in any form immune from civil liability for damages due to data breaches. The proposed law would provide breach liability immunity in an effort to encourage entities to adopt such safeguards.

Florida

Florida has introduced bills (S.B. 586 and H.B. 279) which would require companies to follow federal guidelines when disposing of personal data. The bills would require businesses and government agencies to follow the “Guidelines for Media Sanitization” set by the National Institute of Standards and Technology to make all personal data disposed of by companies and agencies inaccessible. In addition, state agencies would also be required to submit samples of allegedly sanitized storage media to an independent third party vendor to verify the destruction of the personal data. 

New York

A New York data security bill would establish a general encryption standard as a safe harbor for entities seeking to avoid giving breach notice to individuals under the state's data breach notice law. The bill, would also require businesses and state agencies to: Implement and maintain reasonable security safeguards, appropriate to the nature of the information, to prevent unauthorized access to or unauthorized destruction, use, modification, or disclosure of the private information.

Unlike the data security regulations issued under Massachusetts breach notification law, the N.Y. bill does not authorize the promulgation of rules, but rather sets out the encryption standard in the text of the proposed law.The bill would also mandate notification of certain breaches to the state attorney general. Another New York bill would provide tax breaks for businesses that invest in data security.

Health Care Employees Fired For Improperly Accessing Patient's Electronic Health Records

As reported by the December 23 Rochester, Minnesota Post Bulletin, the Mayo Clinic has terminated two medical professionals, a physician and another staff member, after determining that they had inappropriately accessed a patient’s confidential electronic health records (EHRs).

The access highlights what should be a growing concern for health care industry employers: the increased availability EHRs provide about patients’ private information that is otherwise protected by HIPAA. As reported in the Bulletin, according to the President of the Minnesota-based Citizens’ Council on Health Care, “the development of the electronic medical record has allowed all sorts of people to have access” that they would not have had before the advent of EHRs.

As previously reported here, the risks of data breaches and misuses of personal information rise significantly when the information is in electronic format. The trend toward putting more information in electronic format will only continue given the significant cost savings through technological advancements and, for health information, federal subsidies for the adoption of EHRs. Despite protections mandated by law, the portability and availability of EHRs nevertheless facilitate the improper viewing or misuse patients’ protected health information.

The Mayo Clinic terminations come on the heels of a string of employee terminations in 2008 by the UCLA Medical Center, which, through investigations dating back to 2004, found that at least 127 employees had improperly accessed the medical records of celebrities. One employee was even indicted in 2009 after she was found to have purposefully removed the social security numbers of celebrity patients and recorded actor Farah Fawcett’s medical records. Farah Fawcett subsequently sued her.

While most medical providers are well-aware of HIPAA’s requirements, the interest in all things celebrity may be too much for some to resist. We expect that the American Recovery and Reinvestment Act of 2009 (ARRA) [pdf] may only increase the risk of privacy breaches for it provides incentives to health care-related businesses to develop even more extensive uses of electronic health records. However, even famous celebrities have privacy rights under HIPAA, and health care employers should revisit their policies, procedures and training in the area of maintaining patient privacy and more closely monitor the use of electronic medical records.

Electronic Health Records: The Work to Build a Health Information Technology Infrastructure Begins

Co-Author:  V. John Ella, Esq.

In a key step toward developing a proposed U.S. health information technology (HIT) infrastructure, the Centers for Medicare & Medicaid Services has announced that Iowa’s Medicaid program is the first to receive federal matching funds for planning activities necessary to implement the electronic health record (EHR) incentive program established by the American Recovery and Reinvestment Act of 2009 (ARRA). 

ARRA was signed into law by President Obama on February 17, 2009. Among its various parts, ARRA includes provisions for the improvement of our nation’s health care through health information technology (also known as Health IT or HIT), Medicare and Medicaid Health IT provisions which provide incentives and support for the adoption of certified electronic health records (EHRs); and provisions to expand, enforce, and enhance the privacy and security safeguards required by HIPAA. The proposed goal of a switch to EHRs is to improve the quality of health care for individuals, make care more efficient by making it easier for providers treating a patient to coordinate care, and make it easier for individual patients to access the information they need to make decisions about their own health care. Responsibility for implementing this program falls to the National Coordinator for Health Information Technology, a position currently filled by Dr. David Blumenthal at the Department of Health and Human Services (“HHS”). In furtherance of this goal, Mr. Blumenthal recently announced $80 million in grants to develop a HIT workforce. Additionally, the HHS has created a helpful website on the topic of health information technology with links to resources on privacy issues.

In discussing the approximately $1.16 million in federal matching funds Iowa will receive, Cindy Mann, director of the Center for Medicaid and State Operations at CMS said, “While Iowa is the first state to receive approval of its plan for implementing the Recovery Act’s EHR incentive program, a number of other states have submitted plans as well, meaningful and interoperable use of EHRs in Medicaid will increase health care efficiency, reduce medical errors and improve quality-outcomes and patient satisfaction within and across the states.”   As the first state to receive federal funding, Iowa will use the funds to focus on planning, information gathering, analysis, and assessment with respect HIT and the use of EHR within the state.  

A HIT Infrastructure is likely to raise a range of new issues involving the handling of sensitive personal information. For instance, anytime extensive personal and medical information is placed in electronic form, the chance of a data breach or information misuse rises significantly. This is especially true given the recent growth in the area of medical identity theft. Additionally, as some commentators have reported, physicians, hospitals, and clinics have all expressed concerns regarding the technical feasibility of the system, potential for patient mix-ups, as well as the extensive cost to make the switch to EHR. How such a system would affect employers and group health plan administration remains unclear.  

With such an emphasis on a switch to EHR, and billions of federal dollars fueling the conversion, all businesses, particularly health care providers, need to be consider how they will be affected by the new HIT infrastructure. 

HIPAA Data Breaches in India Threaten Outsourcing Industry, Require Greater Vigilance at Home

A British TV station investigation into India's medical transcription industry, known as Business Process Outsourcing (BPO), uncovered unsettling news for British subjects, as well as American citizens. Medical records sent to India to be transcribed and computerized are being sold. The Economic Times report on the investigation out of New Delhi suspects a "hardening of stance on the outsourcing industry by the western world." The article states:

The revelation has forced police of the two countries to join hands to launch an official investigation into the data pilferage of the records stored by the Indian BPOs. If found true, the allegations could hit the flourishing BPO sector in India hard, fueling doubts about their integrity and efficiency.

Security breaches of this kind can have far reaching effects beyond the businesses and individuals directly impacted. The hopes for funding U.S. healthcare reform rest, in part, on administrative cost savings. Under the HITECH Act, enacted as part of the 2009 federal stimulus bill, the U.S. will spend 36 billion to spur the health care industry to purchase and create systems and equipment, including electronic health records systems, to better network the healthcare industry. Reluctance to outsource and increased security are likely to chip away at whatever cost savings can be achieved through enhanced technology in healthcare. 

In the short run, businesses must be more vigilant in vetting their vendors, as well as the vendors of their vendors. These efforts should include stronger agreements, deeper examinations of security protocols, knowing where information is ultimately stored and processed, and having a better understanding of the applicable legal and industry standards concerning data security. These efforts can not stop at the water's edge.