HIPAA regulations

A survey conducted by the Medical Records Institute in 2002 on health care practitioners concerns with the implementation of mobile technology devices and applications cited security/confidentiality when sending or receiving information and the lack of Health Information Portability and Accountability Act (HIPAA) compliance as primary concerns by 50 and 34 percent of respondents, respectively. Confidentiality and security of information against unauthorized access must be HIPAA-compliant. A number of systems are available that can help a pharmacy organization to remain in compliance with HIPAA regulations. Pharmacists are required by law to use reasonable methods to ensure that protected health information remains... 

A single consolidated authorization for the subject, which includes needed authorization for access to data for the clinical trial, can be included with the covered entities authorizations for subject privacy, according to the HIPAA regulations. The drug sponsor s access to the needed data is best handled by a separate authorization from each subject for each clinical trial. In addition, a special authorization for subjects is needed for the release of records that involve psychotherapy notes. Drug sponsors should be sure that a special authorization is available for the drug sponsor s access to psycho therapy notes to complete the trial successfully. 

When first announced, the HIPAA regulations threw some medical researchers and a few designers of medical information systems into a panic mode because of the room for multiple interpretations due to the ambiguity and the absence of best practices. Canadian and European regulations are much more specific and rigid, and they tend to be clearer as to interpretation that suggests best practices. These privacy laws also cover all the industries, not just healthcare industry. 

The nurse cannot talk to the client s daughter because of HIPAA regulations. 

The United States Department of Health and Human Services established the Health Insurance Portability and Accountability Act (HIPAA) in 1996, which, in part, protects the privacy and security of private health information. Dental care and history is considered private health information and is, therefore, protected by HIPAA regulations. Dental practices must adhere to strict guidelines to maintain patient confidentiality and improve patient safety. 

For specific language and details concerning the informed patient consent and data use agreement, sponsors should review the information avail able from the Department of Health and Human Services Centers for Medi care and Medicaid Services or their privacy officers. (Seehttp //www.cms.hhs.gov/hipaa.) Another useful link to a guidance document specifically re lated to research under the HIPAA privacy regulations can be accessed at http //www.hhs.gov/ocr/hipaa/guidelines/research.pdf. (See Chaps. 20 and 24.)... 

So change is upon us. Slower than other industry verticals (like capital markets and financial services)—reflecting the very conservative and risk adverse nature of the life sciences industry. But there are still insufficient standards in place with a number of relatively new regulatory implications such as 21 CFR Part 11 and HIPAA—further complicated by varying interpretations of these regulations. And change itself is costly and resource intensive and must deal with behavioral modification and human nature s resistance to change. 

In 1996, the DHHS passed the Health Insurance Portability and Accountability Act (HIPAA) to facilitate the sharing of information while protecting patient confidentiality (medical records) subsequently, associated privacy regulations were issued in 2000 (Privacy Rule). Amendments to the Privacy Rule were proposed on March 27, 2002, to address research-related situations, and become effective on April 14, 2003. In essence, the Privacy Rule is the governing law for the use and disclosure of individually identifiable protected health information (PHI) by covered entities, defined as health care providers, health plans, or health clearing houses. HIPAA-compliant consents that include elements specified in federal regulations (45 CFR 164.508) will have to be provided by covered entities that carry out the activities of health care payment, treatment, or operations (PTO). Clinical research-related uses and/or disclosures of PHI beyond PTO will require that a specifically defined authorization be obtained from a research subject. HIPAA-compliant authorizations will have to include the following core elements ... 

HIPAA and the Administration Simplification Provisions cover the electronic transactions and code sets, national identifiers for plans and providers, and employers and will include subjects, security, and privacy provisions that were intended to balance the simplification of the transaction and identifiers. The HIPAA privacy regulations are in Title 45 of the Code of Federal Regulations. Those who work in research and are familiar with the common rule, IRB, and informed consent regulations, also in Title 45, part 46. Administrative simplification and privacy rules can be found in Title 45, parts 160 and 164. 

One specific area of concern for many safety professionals has been, Do HIPAA and patient confidentiality rights extend to DOT required drug and alcohol testing The answer that the DOT and FMCSA regulations do not require the driver s signature on anything except the CCF and ATF did not ease many safety professional s worries. 

Communication interfaces are used for exchanging data between the RIS informatic system and adjacent software applications. They are compatible with the HL7 standard and use the TCP/IP communication protocol. All interfaces are compliant with the HIPAA (Health Insurance Portability and Accountability Act) regulations. Some of these interfaces are designed based on the IHE specifications. Figure 3 describes the connection between the RIS server and other medical informatics systems (HIMSS and RSNA, 2005). 

Jastone, L.O., Federal Protection for Human Research Subjects An Analysis of the Common Rule and its Interactions unth FDA Regulations and the HIPAA Privacy Rule (New York, Novinka Books, 2006). 

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