Confidentiality of Medical Records:
Vehicle identifiers and serial numbers, including license plate numbers Device identifiers and serial numbers Web Universal Resource Locators URLs Internet Protocol IP address numbers Biometric identifiers, including finger and voice prints Full-face photographic images and any comparable images Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re-identification.
A Limited Data Set is similar to the de-identified data set but has fewer of the 18 identifiers removed. The Limited Data Set is health information that may include city, state, zip code, elements of date, and other numbers, characteristics, or codes not listed as direct identifiers.
Limited data sets are often utilized in multi-center studies when using fully de-identified data is not useful. The use of a Limited Data Set allows a researcher and others to have access to dates of admission and discharge, birth and death, and five-digit zip codes or other geographic subdivisions other than street address.
It requires that the researcher neither re-identify the data nor contact the research participant and contains assurances that appropriate safeguards will be used to prevent improper use or disclosure of the Limited Data Set. It may, therefore, be necessary for covered entities to properly use and disclose individually identifiable health information in compliance with both sets of regulations.
It is mandatory to report positive HIV test data to state health departments. Depending on the state where the research is conducted, Waivers of Authorization may not be permitted with fully identified HIV data.
However, different institutions vary in their policies concerning decedent research. To use or disclose PHI of deceased persons for research, covered entities are not required to obtain an Authorization, a Waiver, an Alteration of the Authorization, or a Data Use Agreement from the personal representative or next of kin.
Department of Health and Human Services Obviously, Public Health services provide important essential public health protections. Consequently, various federal and state laws, as well as the policies of various medical and healthcare professional organizations and institutions, provide confidentiality protections for adolescents.
Some institutions have developed policies that would require disclosing information to parents in certain circumstances, such as in suicide research if there are threats of suicide by children, adolescents, or college students. Civil penalties usually involve monetary fines.
Covered entities and individuals e. Research participants must be given fair, clear, honest explanations of what will be done with information that has been gathered about them and the extent to which confidentiality of records will be maintained.
However, the promise of confidentiality cannot be absolute. Under court order or subpoena for example, there may be legal reasons for compelling a researcher to disclose the identity of, or information about, a research participant.
In some instances, a researcher may be mandated to report information to government agencies as in cases of child abuse or elder abuse, certain communicable diseases, illegal drug use, and other situations such as gunshot wounds.
When research is conducted across multiple sites, review how the information is being protected. Identify and limit the number of people having access to the data, particularly when data are being transferred across locations, and be aware of when data are reproduced in other formats, such as faxes or computer files.
Make sure that duplicated information is properly destroyed when transferring data.
Review confidentiality procedures during the continuing review of protocols by reexamining the protection of sensitive information and the success of the protection efforts.
Educate researchers, research coordinators, and IRB staff on data management and data protection. Also perplexing, are situations in which the IRB must determine which safeguards should be in place to protect past participants who need to be contacted to sign a new Informed Consent Form.
Behavioral and social sciences research conducted at a university that is not a covered entity may not fall under the HIPAA regulations.
Protections could include the encryption of the data, authentication, and authorization of passwords for those who have access to the data, software security, and electronic and physical security of data storage devices and networks. Designing study-specific protections for confidentiality requires planning, diligence, time, and knowledge of privacy and confidentiality strategies and procedures.
It is important to develop a specific Data Protection Plan. A plan would include: A key that deciphers the code allows re-associating or linking the coded information with the identity of the participant.
If applicable, codes may need to be protected by an outside agency or third party. It is important that a clear policy be defined for re-identification.Health information managers are uniquely qualified to serve as health information stewards, with an appreciation of the various interests in that information, and knowledge of the laws and guidelines speaking to confidentiality privacy and security.
The confidentiality of personal health information, thus, is an issue that profoundly affects every American, and the fundamental question, to quote U.S. department of Health and Human Services Secretary Donna E.
Shalala, PhD, is: "Will our health records be used to heal us or reveal us?". In another survey, 83 percent of respondents reported that they trust health care providers to protect the privacy and confidentiality of their personal medical records and health information (Westin, ).
However, in that survey, 58 percent of respondents believed the privacy of personal medical records and health information is not protected well .
1: Why are privacy and confidentiality of fundamental importance in research? Given our modern research setting, with growing dependence on computers, the Internet, and the need for databases and registries, protection of an individual’s privacy is now one of the greatest challenges in research.
So accordingly, notions of ‘confidentiality’ and ‘privacy’ will be of utmost importance, however, we should point out that while most of us would deem the terms as interchangeable, there are differences which exist when talking about our personal health records.
|Learn about the Law||In studies where patients were able to provide unstructured comments, they expressed concern about the potential that anonymized data would be reidentified. They were also concerned that insurers or employers or others who could discriminate against subjects could potentially access informa tion maintained by researchers Damschroder et al.|
|CONCEPTS AND VALUE OF PRIVACY||Full Answer Maintaining confidentiality is a key component of any field, as well as personal relationships.|
Health care is changing and so are the tools used to coordinate better care for patients like you and me. During your most recent visit to the doctor, you may have noticed your physician entering notes on a computer or laptop into an electronic health record (EHR).