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University of Mississippi Medical Center Agrees to Pay $2.75M to Settle Potential HIPAA Violations

July 25, 2016
by Heather Landi
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The University of Mississippi Medical Center (UMMC) has signed a resolution agreement with the U.S. Department of Health and Human Services Office for Civil Rights (OCR) following an investigation of a data breach of unsecured protected health information (ePHI) that occurred in 2013.

As part of the settlement due to multiple alleged violations of the Health Insurance Portability and Accountability Act (HIPAA), UMMC will pay a penalty of $2.75 million and adopt a corrective action plan designed to assure future compliance with HIPAA Privacy, Security and Breach Notification Rules, according to an OCR announcement.

OCR’s investigation of UMMC was triggered by a breach of unsecured ePHI affecting approximately 10,000 individuals. “During the investigation, OCR determined that UMMC was aware of risks and vulnerabilities to its systems as far back as April 2005, yet no significant risk management activity occurred until after the breach, due largely to organizational deficiencies and insufficient institutional oversight,” the agency stated in the announcement.

“In addition to identifying risks and vulnerabilities to their ePHI, entities must also implement reasonable and appropriate safeguards to address them within an appropriate time frame,” OCR Director Jocelyn Samuels said in a prepared statement. “We at OCR remain particularly concerned with unaddressed risks that may lead to impermissible access to ePHI.”

University of Mississippi is the state’s sole public academic health science center with education and research functions. In addition it provides patient care in four specialized hospitals on the Jackson campus and at clinics throughout Jackson and the state. Its designated health care component, UMMC, includes University Hospital, the site of the breach in this case, located on the main UMMC campus in Jackson.

On March 21, 2013, OCR was notified of a breach after UMMC’s privacy officer discovered that a password-protected laptop was missing from UMMC’s Medical Intensive Care Unit (MICU). According to HHS OCR, UMMC's investigation concluded that it had likely been stolen by a visitor to the MICU who had inquired about borrowing one of the laptops. OCR’s investigation revealed that ePHI stored on a UMMC network drive was vulnerable to unauthorized access via UMMC’s wireless network because users could access an active directory containing 67,000 files after entering a generic username and password. The directory included 328 files containing the ePHI of an estimated 10,000 patients dating back to 2008.

OCR also stated that during its investigation into the data breaches the agency found that UMMC failed to implement its policies and procedures to prevent, detect, contain, and correct security violations and failed to implement physical safeguards for all workstations that access ePHI to restrict access to authorized users. In addition, OCR cited UMMC for failing to assign a unique user name and/or number for identifying and tracking user identity in information systems containing ePHI as well as failing to notify each individual whose unsecured ePHI was reasonably believed to have been accessed, acquired, used, or disclosed as a result of the breach.

 

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Should HIPAA Privacy Rules Change? HHS Seeks Input

December 13, 2018
by Rajiv Leventhal, Managing Editor
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The Office for Civil Rights (OCR) has issued an RFI seeking input from the public on how Health Insurance Portability and Accountability Act (HIPAA) Rules, particularly the HIPAA Privacy Rule, could be modified to reflect the administration’s goal of promoting coordinated, value-based care.

As the government noted in a press release on the RFI, “HHS developed the HIPAA Rules to protect individuals’ health information privacy and security interests, while permitting information sharing needed for important purposes. However, in recent years, OCR has heard calls to revisit aspects of the Rules that may limit or discourage information sharing needed for coordinated care or to facilitate the transformation to value-based healthcare.”

Now, the RFI serves to request “information on any provisions of the HIPAA Rules that may present obstacles to these goals without meaningfully contributing to the privacy and security of protected health information (PHI) and/or patients’ ability to exercise their rights with respect to their PHI.”

In addition to requesting broad input on the HIPAA Rules, the RFI also seeks comments on specific areas of the HIPAA Privacy Rule, according to HHS, including:

  • Encouraging information-sharing for treatment and care coordination
  • Facilitating parental involvement in care
  • Addressing the opioid crisis and serious mental illness
  • Accounting for disclosures of PHI for treatment, payment, and health care operations as required by the HITECH Act
  • Changing the current requirement for certain providers to make a good faith effort to obtain an acknowledgment of receipt of the Notice of Privacy Practices

“This RFI is another crucial step in our Regulatory Sprint to Coordinated Care, which is taking a close look at how regulations like HIPAA can be fine-tuned to incentivize care coordination and improve patient care, while ensuring that we fulfill HIPAA’s promise to protect privacy and security,” said Deputy Secretary Eric Hargan.

He added, “In addressing the opioid crisis, we’ve heard stories about how the Privacy Rule can get in the way of patients and families getting the help they need. We’ve also heard how the Rule may impede other forms of care coordination that can drive value. I look forward to hearing from the public on potential improvements to HIPAA, while maintaining the important safeguards for patients’ health information.”

Comments are due by Feb. 11, 2019.

 

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AMIA Calls for Harmonization of Data Privacy Policies

November 16, 2018
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As the lines between consumer and clinical data systems continues to blur, there is a need to harmonize health sector data privacy policy, such as the Health Insurance Portability and Accountability Act (HIPAA) and consumer data policy to develop a new era of privacy policy, according to the American Medical Informatics Association (AMIA).

AMIA provided written comments last week in response to the National Telecommunications and Information Administration’s Request for Comment (RFC) on the Administration’s approach to consumer privacy. NTIA, an agency within the Department of Commerce, was seeking feedback on ways it can advance consumer privacy while also protecting innovation. The RFC sought feedback on how certain organizational privacy goals and outcomes can be achieved. These outcomes include organizational transparency, user control over personal information, reasonable minimization of data collection, organizational security practices, user access and correction, organizational risk management, and organizational accountability.

In its written comments, AMIA encouraged the Trump administration to closely examine both HIPAA and the Common Rule and develop an explicit goal to harmonize “health sector” and “consumer sector” data privacy policies. The informatics group cautioned the Administration against a patchwork of consumer privacy policies that is already the norm in the health sector.

Jeff Smith, vice president, public policy at AMIA, notes that given the health sector’s experience with HIPAA and the Common Rule, there is a unique opportunity to accomplish two aims with this executive and legislative branch conversation—harmonize health sector data privacy policy with consumer data privacy policy and develop a national forum and framework to allow states flexibility to address local needs and norms.

In its written comments, AMIA noted that differences in the interpretation of HIPAA have led to wild variations in application. The group thus urged the administration to balance the need for both prescriptive process-oriented policies and outcome-oriented policies, writing that “[a]n over-emphasis on vague or difficult-to-measure outcomes without guidance on process will result in the failings of HIPAA – wide variation in interpretation and inconsistent implementation.”

AMIA went on to not only reiterate its support for patients always having access to their data, but advocated extending this principle to other sectors of the economy and elevating it to “a prerequisite condition and central organizing principle from which other outcomes derive.”

Further, while AMIA broadly supported the RFC’s high-level goals, it recommended that the administration also focus on “closing regulatory gaps” that endanger data privacy. Citing a 2016 ONC report, AMIA pointed out that there are health-related technologies that exist outside the scope of HIPAA, Federal Trade Commission (FTC) regulation, or state law. Thus, a truly comprehensive approach to consumer privacy should address these gaps, AMIA wrote.

Finally, AMIA encouraged the administration to take several steps to address data governance and ethical use. It recommended that FTC “develop a framework for organizations to use that supports trust, safety, efficacy, and transparency across the proliferation of commercial and nonproprietary information resources,” in addition to an “ethical framework around the collection, use, storage, and disclosure of the personal information consumers may provide to organizations.”

“We applaud the administration for initiating this long overdue conversation. As the lines between consumer and clinical devices continues to blur, the need for harmonized federal policy becomes more pronounced,” Douglas B. Fridsma, M.D., Ph.D, AMIA President and CEO, said in a statement. “Just as we strive to ensure that patients have access to and control over their data, we must strive to deliver the same for consumers. The administration should learn from the health sector and develop improved privacy policies across all sectors of the economy.”

 

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Time to End ‘Wild West’ of Health Data Usage in HIPAA-Free Zones

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Beyond consent, bioethicists argue for ethical guidelines governing fair use of data
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In a recent conversation, a CMIO described the era of Meaningful Use and ICD-10 to me as the “doldrums of regulatory reform” that “sucked up all the oxygen” in the industry, leaving little room for innovation. So I can see why there would be little appetite for more regulation related to health data, and obviously the current administration prefers market-based solutions to regulatory ones.

Yet the Oct. 22 meeting, “Data Min(d)ing: Privacy and Our Digital Identities,” put on by the U.S. Department of Health & Human Services, made it clear to me that as more health data is gathered (and sold) outside the clinical setting, there is a “Wild West” atmosphere in which pretty much anything goes in terms of what companies not covered by HIPAA can do with our health data.

As an example, an April 2018 CNBC article noted that Facebook “has asked several major U.S. hospitals to share anonymized data about their patients, such as illnesses and prescription information, for a proposed research project. Facebook was intending to match it up with user data it had collected in order to help the hospitals figure out which patients might need special care or treatment.” (That project is currently on hiatus, Facebook said.)

The HHS meeting brought together industry leaders and researchers for some thought-provoking presentations about the many ways genetic, wearable and EHR health data is being used. For instance, James Hazel, Ph.D, J.D., a research fellow at the Center for Biomedical Ethics and Society at the  Vanderbilt University Medical Center, presented his research that involved a survey of the privacy policies proffered by U.S. direct-to-consumer genetic testing companies. Hazel noted that there has been huge growth in direct-to-consumer genetic testing, with an estimated 12 million people tested in the United States. Beyond offering consumers the services, these companies doing the testing wish to monetize that data through partnerships with pharmaceutical companies and academic researchers. There is also value to government and law enforcement officials – to solve cold cases, for instance.

There is a patchwork of federal and state laws governing disclosure of secondary data usage to consumers, but the industry is largely left to self-regulate, he said. In his survey of 90 companies offering these genetic data services, “10 percent had no policies whatsoever,” he said. About 55 companies had genetic data policies, but there was tremendous variability in policies about collection and use. Less than half had information on the fate of the sample. In terms of secondary use, the majority of policies refer to internal uses of genetic data. However, very few addressed ownership or commercialization. And although almost all made claims to being good stewards of the data, 95 percent did not provide for notification in case of a data breach. The provisions for sharing de-identified data are even less restrictive. Hazel noted that 75 percent share it without additional consent from the consumer.

Hazel’s take-home message: “We saw variability across the industry. Also, we had a group of law students and law professors read the policies and there was widespread disagreement about what they meant,” he said. “Also, nearly every company reserves the right to change the policy at any time, and hardly any company provided for individual notice in event of a change.” He finished his presentation with a question. “What is the path forward? Additional oversight by the Federal Trade Commission? Or allowing industry efforts to take the lead before stepping in?”

In a separate presentation, Efthimios Parasidis, J.D., a professor of Law and Public Health at the Ohio State University, spoke about the need for an ethical framework for health data.

Parasidis began by noting that beyond data security and privacy, consent and notice are inadequate ethical markers. “If one looks at regulations, whether it is HIPAA, the European Union’s GDPR, or California’s recently enacted consumer privacy law, the regulatory trend has been to emphasize consent, deletion rights and data use notifications,” he said. While these are important regulatory levers, missing is a forum for assessing what is fair use of data. “Interestingly, few areas of data collection require ethics review,” he stressed. HIPAA does not speak to when data use is ethical but rather establishes guidelines for maintaining and sharing certain identifiable health information. Even those protections are limited. HIPAA only applies to covered entities, he noted. It does not apply to identifiable health information held by a wide variety of stakeholders, including social media, health and wellness apps, wearables, life insurers, workers’ compensation insurers, retail stores, credit card companies, Internet searches, and dating companies.

“While the volume of identifiable health information held in HIPAA-free zones engulfs that which is protected by HIPAA and may support more accurate predictions about health than a person’s identifiable medical records,” Parasidis said, “the limits of HIPAA’s protections go beyond scope. For data on either side of the HIPAA divide, an evaluation of ethical implications is only required for human subject research that falls under the Common Rule. Much of data analytics falls outside the Common Rule or any external oversight.”

Citing the Facebook example mentioned above, Parasidis noted that tech giant Amazon, Apple, Google, Microsoft and Uber are entering the digital health space. “The large swathes of identifiable information that these entities hold raise a host of ethical questions,” he added, “including widespread re-identification of de-identified health information, health profiling of individuals or groups and discrimination based on health conditions.”

Policies and guidelines can supplement the small subset of data covered under legally mandated ethics review, he explained. For instance, federal agencies sometimes use internal disclosure review boards to examine ethical implications of data disclosure. But it is not clear this type of review is happening in the private sector.

Parasidis described work he has done with Elizabeth Pike, director of Privacy Policy in the Office of the Chief Information Officer at HHS, and Deven McGraw, who served as deputy director of health information privacy at HHS, on a framework for ethical review of how health data is used.

One way to think about more robust ethics review is the use of data ethics review boards, he said. Their structure can be modeled on institutional review boards or disclosure review boards. “This new administrative entity is necessary because much of contemporary data analytics falls outside existing frameworks,” he said. “We argue that these boards should focus on choice, responsiveness, accountability, fairness and transparency — a CRAFT framework. For instance, choice goes beyond consent. Individuals have an ongoing interest in their health data and should be able to specify how it is collected, analyzed and used.”

Reasonable minds can disagree on the relative weight of ethical principles or how they should be enacted into the context of data use deliberations, he said. “We nevertheless believe there remains an urgent need to craft an ethical framework for health data.”

 

 

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