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Simplification would also be very helpful for smaller or community-based institutions that do not have internal counsel or regulatory affairs specialists, and are thus more likely to opt out of research that requires decisions about authorizations. A second situation where a covered entity is permitted to use and disclose PHI without obtaining authorization is for activities that are preparatory to research. A covered entity may permit researchers to look through its medical records in order to develop research protocols and to aid the recruitment of research participants if it obtains from the researcher representations that the information sought is necessary for the research purpose, that information will be reviewed only for the stated purposes preparatory to research, and that no PHI will be removed from the covered entity by the researcher in the course of the review 45 HHS, a.

Many research studies, especially those focused on rare conditions with limited eligible patient populations, rely on large-scale medical chart reviews and searches of patient databases to identify patients who might be eligible for and might benefit from a particular study. Sufficient patient enrollment in a timely fashion is essential to ensure the meaningfulness and reliability of the research results.

However, confusion regarding what is permitted under this component of the Privacy Rule is widespread SACHRP, , and surveys and studies indicate that patient recruitment has become more difficult and costly under the varying interpretations of the Privacy Rule see Chapter 5. HHS has issued multiple guidance statements on this topic, but these statements, some of which have been contradictory, have failed to eliminate confusion reviewed by SACHRP, According to current HHS guidance on the Privacy Rule, researchers both internal and external to a covered entity may conduct a review of medical records under the preparatory to research exception.

HHS guidance on the Privacy Rule indicates that external researchers are not allowed under the preparatory to research exception to record or remove contact information of patients from a covered entity.

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This creates an artificial distinction between internal and external researchers that actually provides less privacy protection than that afforded by the Common Rule , which requires that any activities preparatory to research involving human subjects, or related to initial recruitment of subjects for research studies, be reviewed and approved by an IRB HHS, Moreover, research shows that patients prefer to be approached by their clinician or an associated nurse as opposed to a stranger Damschroder et al.

It appears, for example, that in some institutions, boilerplate business associate contracts are being signed, and that template applications for partial waivers of authorization are being routinely granted, as methods of perfunctory compliance with these confusing Privacy Rule requirements. The third situation where a covered entity is permitted to disclose PHI without authorization is for research using the PHI of decedents.

These representations include:. Apparently some covered entities interpret the Privacy Rule more conservatively by requiring researchers to obtain authorization from next of kin, or a waiver of authorization from an IRB or Privacy Board , in order to access the PHI of decedents Ness, Deidentified information does not qualify as PHI, and therefore is not protected under the Privacy Rule—it can be disclosed to researchers at any time HHS, c.

The Privacy Rule offers two methods to deidentify personal health information.

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Under the statistical method, a statistician or person with appropriate training verifies that enough identifiers have been removed that the risk of identification of the individual is very small. Furthermore, the covered entity may not disclose the key to the code to anyone else. These provisions are more stringent than those of the Common Rule , leading to situations in which some coded data might be subject to the Privacy Rule, but not the Common Rule Rothstein, But because IRBs have not had to review these protocols in the past, they may find it difficult to make appropriate decisions about waivers.

The Privacy Rule restrictions put greater emphasis on the possibility that health data could be reidentified using publicly available databases. Determining what information can be released without inappropriately compromising the privacy of the individual respondents is inherently a statistical issue Fienberg, see also discussion on privacy-preserving data mining and statistical disclosure limitation in Chapter 2.

For example, an academic exercise showed that it was possible to identify the names and addresses of 97 percent of the registered voters in Cambridge, Massachusetts, using the birth date and full postal code Sweeney, Studies indicate that even after removal of the 18 identifiers required under the safe harbor method of the Privacy Rule, recipients could reidentify individuals in a study dataset with a moderately high expectation of accuracy by applying only diagnosis and medication combinations Clause et al.

However, strong security measures as recommended in Chapter 2 and the implementation of legal sanctions against the unauthorized reidentification of deidentified data as recommended in subsequent sections of this chapter may be more effective in protecting privacy than more stringent deidentification standards. Likewise, treatment dates are essential information for determining treatment effects, including adverse side effects.

Concerns were also raised that deidentification would impede longitudinal studies, and subsequent research has indicated that information deidentified using the safe harbor method of removing all of the listed identifiers results in lost chronological spacing of episodes of care Clause et al. To qualify as a limited dataset, 16 of the more direct identifiers—such as names, addresses, Social Security numbers, and medical telephone numbers—must be removed from the data.

However, the following elements may be included in a limited dataset: city, state, ZIP Code, elements of date, and other numbers, characteristics, or codes not listed as direct identifiers in the regulation including HMAC. A limited dataset may be created by a covered entity or the covered entity can enter into a business associate agreement with another party, including the intended recipient, to create the limited dataset on its behalf. To disclose a limited dataset for research without individual authorization, the covered entity must enter into a data use agreement with the recipient.

These contracts specify the recipient of the limited dataset and require the recipient to agree to a number of conditions, including:. France reportedly uses the equivalent of limited datasets from numerous hospitals to conduct epidemiologic research Berman, , but the French health care system and legal environment are quite different than in the United States. For example, in some health care settings, it can be challenging to identify an individual who will sign a data use agreement on behalf of the covered entity and thus manage the contract according to the perceived risk and obligation to monitor how that limited dataset is used.

At the other extreme, it was noted that some covered entities were signing data use agreements as a matter of course, and thus providing little meaningful privacy protection to the patient IOM, Thus, the committee recommends that HHS encourage greater use of limited datasets and develop clear guidance on how to set up and comply with the associated data use agreements more efficiently and effectively.

The Privacy Rule addresses data aggregation only with respect to health care operations, 59 not research. More commonly, data are provided to researchers with direct identifiers removed. A third party may also collect PHI from covered entities and aggregate the data for research by establishing business associate agreements BAs with the various data sources, but in practice, BAs are used infrequently for this purpose AcademyHealth, This approach is complicated and impractical to set up for individual research projects. Moreover, BAs can be established by covered entities to gain competitive advantage, rather than to collaborate in research.

The committee believes that a better approach would be to establish secure, trusted, nonconflicted intermediaries that could develop a protocol, or key, for routinely linking data without direct identifiers from different sources and then provide more complete and useful deidentified datasets to researchers. One way this could be accomplished, for example, might be through data warehouses that are certified for the purpose of linking data from different sources IOM, The organizations responsible for such linking would be required to use strong security measures and would maintain the details about how this linkage was done, should another research team need to recreate the linked dataset.

Using such intermediaries would increase patient privacy protections and allay concerns of covered entities, and thus would facilitate greater use of health data for research and also lead to more meaningful study results. CMS provides a similar service for Medicare and Medicaid data, via contractors who create standardized data files that are tailored for research Box The agency has begun pilot projects to aggregate Medicare claims data with data from commercial health plans and, in some cases, Medicaid, in order to calculate and report quality measures for physician groups.

The Chronic Conditions Warehouse. Department of Health and Human Services to make Medicare data more readily available to researchers more The HIPAA administrative simplification provisions specifically provided for the creation of a unique individual identifier, but work on this project has been halted because there is a great deal of controversy regarding how it could be implemented without comprising individual privacy.

Federal agencies are also under pressure from the Office of Management and Budget to reduce the use of Social Security numbers as unique identifiers. But the development of some type of linking key not based on Social Security numbers would make linkages more efficient, standardized, and reliable and less costly. Moreover, this type of linkage could greatly facilitate many types of information research, provide more extensive health histories and facilitate public health surveillance, and improve quality of care HHS, ; Hillestad et al.

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Research involving genetic information presents perhaps some of the most challenging areas for protecting the privacy of health information Bregman-Eschet, ; Farmer and Godard, ; Greely, ; NBAC, New knowledge of the human genome, combined with advances in computing capabilities, are expected to help decipher the roles that genetics and the environment play in the origins of complex but common human diseases, such as cancer, heart disease, and diabetes.

In this genomic age of health research, patient samples stored in biospecimen banks can provide a wealth of information for addressing long-standing questions about health and disease, and efforts are underway to create large genomic databases for that purpose Adams, ; Greely, ; Lowrance, ; Lowrance and Collins, However, it is particularly difficult to assess the potential harms to individuals who are the subjects of research in these rapidly advancing areas NBAC, ; Pritts, , and precedent does not appear to provide sufficient guidance in this relatively uncharted territory Lowrance, ; Lowrance and Collins, HHS has further stated that the results of an analysis of blood or tissue, if containing or associated with personally identifiable information, would be PHI.

Genetic information does not itself identify an individual in the absence of other identifying information. As genetic information becomes more prevalent in research and health care, the latter scenario is more likely to occur. For example, in January , the NIH began requiring data from the Genome Wide Association Study 63 to be submitted to a central databank in an anonymous and aggregated form. That database was publicly accessible until August when officials at NIH removed the database from the public Website, citing concerns about patient confidentiality Couzin, ; Zerhouni and Nabel, NIH intends to move the aggregate genotype data to a secure, controlled-access database with policies for review and approval of data access requests Zerhouni and Nabel, But at the same time, realization of the promises of personalized medicine will require research on DNA from a great many diverse individuals whose medical histories are well documented.

Therefore, the committee believes that the establishment of consistent standards for use and protection of genetic information is important and advocates a focus on strong security measures.

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In addition, it recommends the adoption of strict prohibitions on the unauthorized reidentification of individuals by anyone from DNA sequences. Regardless of how genetic information is regulated under the HIPAA Privacy Rule, a federal prohibition of genetic discrimination is necessary to allay privacy concerns and diminish potential negative consequences of unintended disclosure of genetic information. In addition, the AOD requirement does not constitute an audit trail, as there are numerous exceptions to the requirement, including disclosures for health care operations, pursuant to an authorization, as part of a limited dataset, for national security or intelligence purposes, and to correctional institutions or law enforcement official.

Therefore, AOD cannot provide individuals with some of the information they may want, such as a list of employees who looked at their medical record when they were in the hospital AHIC, ; Pritts, Disclosures made for research purposes under a waiver of authorization, or for public health purposes as required by law, must be included in the AOD. Furthermore, in many medical facilities, that list is very extensive, and thus is relatively meaningless to a particular patient. This aspect of the Privacy Rule places a heavy administrative burden on health systems and health services research that achieves little in terms of protecting privacy.


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Moreover, HHS has not given covered entities any guidance on practical ways to fulfill this requirement in an efficient manner. Furthermore, the surveys have found that the demand for AOD is extremely low. Two-thirds of respondents reported receiving no requests at all. To date, no efforts have been undertaken to identify organizations that have successfully implemented the AOD requirement, or the practices that they have put in place Pritts, SACHRP made a similar recommendation, stating that the Privacy Rule imposes sufficient privacy protections without applying this portion of the Privacy Rule to research.

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Indeed, SACHRP concluded that the cost and burden of compliance with AOD requirements was so high that institutions were likely to accept the risk of noncompliance rather than incur the cost of compliance. The IOM committee concurs, and recommends that HHS reform the requirements for the accounting of disclosures of protected health information for research. In the interest of transparency, institutions should maintain a list, accessible to the public, of all studies approved by an IRB or Privacy Board, in place of the AOD requirement. However, as the health care system moves toward broader implementation of electronic health records, automatic tracking of audit trails will be an important component to incorporate.

The Privacy Rule sets out both civil and criminal penalties for covered entities that breach the Rule. The Privacy Rule does not provide for a private right of action by patients or research participants. OCR is in charge of enforcement and decides whether and when to pursue a regulatory investigation and penalties against a covered entity Stevens, In addition, it is important to note that this does not prevent an individual from pursuing a private right of action under state law Pritts, The Compliance and Enforcement regulations stress cooperative compliance over the imposition of penalties reviewed by Pritts, The regulations specifically provide that the Secretary will, to the extent practicable, seek the cooperation of the covered entity in obtaining compliance.

Also, a covered entity that is itself in compliance with the Privacy Rule will not be held liable for the actions of a business associate that breaches the terms of its business associate agreement. A covered entity that knows of a pattern of activity or practice of a business associate that constitutes a material breach of its contract must take reasonable steps to cure the breach or end the violation. Most of the complaints have been filed against health care providers, including physician practices, general hospitals, pharmacies, and outpatient clinics, and largely deal with health information uses, disclosures, and safeguards.

In the majority of cases, OCR determined that the complaint did not present an eligible case for enforcement, either because OCR lacked jurisdiction, the complaint was untimely, or the activity did not violate the Privacy Rule. To date, there have been no civil penalties imposed against any covered entity for breaching the Privacy Rule. Similarly, there have only been three criminal prosecutions under the Privacy Rule of individuals involved in medical identity theft Rahman, In surveys, many providers and payors self-report that they are not in compliance with the Privacy Rule.

In a recent survey by Phoenix Health Systems, 20 percent of providers and 13 percent of payors reported that they have had insufficient incentives to incur the cost of implementing all the requirements of the Privacy Rule. In the survey, none of the participating providers was able to show that it had complied with every provision of the Privacy Rule. Payors only reported doing marginally better Phoenix Health Systems, More than half the respondents indicated that resources were the most significant barrier to full privacy compliance, noting a particular need to support education and training of new staff.

Several other federal statutes regulate research and affect the types of research projects that can be carried out in the United States. Both the Common Rule and the FDA regulations are concerned primarily with the physical risks to humans associated with participation in a research study. Neither set of regulations provides detailed and prescriptive regulations for the protection of privacy HHS, Nonetheless, there are numerous instances in which the Privacy Rule and the Common Rule diverge, as described above.

The Privacy Rule also often interacts with other federal laws. In the preamble to the Privacy Rule, HHS stated that there should be few instances where the Privacy Rule conflicts with existing statutes or regulations. Where potential conflicts do exist, HHS stated that an attempt should be made to resolve the conflict so that both laws apply.

For example, if a statute or regulation permits the dissemination of PHI, but the Privacy Rule prohibits the use or disclosure of PHI without authorization, the covered entity is able to comply with both sets of laws. As a result, covered entities are often subject to both the Privacy Rule and other federal statutes and regulations simultaneously. Medicare providers must comply with the requirements of the Privacy Rule and the Privacy Act of Health care providers in schools, colleges, and universities must comply with the Privacy Rule and the Family Educational Rights and Privacy Act.

There are innumerable examples where the Privacy Rule and another federal statute both must be followed HHS, In general, the Privacy Rule preempts contrary state laws relating to the privacy of health information.

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