HIPAA Privacy Rule: The Effects of the HIPAA Privacy Rule on Clinical Research
The positive and negative effects the HIPAA Privacy Rule has on clinical research
The HIPAA Privacy Rule was issued by the United States Department of Health and Human Services (HHS) in accordance with the Health Insurance Portability and Accountability Act of 1996. Its major goals is to ensure that people's health information is protected and at the same time allows the necessary flow of health information that is required to guarantee the health of the public and to promote quality health care (HHS, 2015). The rule covers health care clearing houses, health plans, and health care providers who deal with the electric transmission of health information, referred to as 'covered entities' by HIPAA standards.
One of the major ways clinical research benefits from this rule is through the time and resources saved, which would have otherwise been lost due to interruptions from privacy infringement allegations and lawsuits. According to the National Institute of Health - NIH (2015), maintaining the privacy of information is crucial in health care and those who fail to adhere to the set rules have to be reprimanded. In the past, researchers had to spend a lot of time establishing the lines they...
Since the HIPAA legislation outlines specific physical, administrative, and technical safeguards that will guarantee the protection of patient information, it is easier for researchers to gather the relevant information they need for research (HHS, 2015). Furthermore, sophisticated technologies used in the implementation of HIPAA enable the provision of audit trails for all who provided and accessed private information, hence it will be easier to catch defaulters. When patients are satisfied with the standardization, and they feel protected by the law, they will be more inclined to participate in research.
The greatest disadvantage of the HIPAA Privacy Law to the field of clinical research has got to do with the numerous rules and regulations it stipulates - creating barriers to new discoveries and advancement in medical research. The Association of Academic Health Centers (2015) conducted a research that involved vice presidents, focus groups, administrators and leaders in research in an attempt to find out the effect HIPAA has on research efforts. They established that the legislation was ambiguous and made recruitment of participants hard, and…
