HIPAA's Impact on Clinical Research Privacy

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Issue The Health Insurance Portability and Accountability Act of 1996 was created to improve the efficiency and effectiveness of the health care system. There are numerous rules that fall under this act, which include Privacy, Security, Enforcement, Omnibus, and Breach Notification Rule. All of which set a national standards of protection, confidentiality, and integrity. HIPAA is to protect those who are patients in any medical facility. Researchers who conduct interventional clinical research have put into question the Privacy Rule and how it will affect their research activities. The Department of Health and Human Services, Food and Drug Administration and Protection of Human Subjects Regulations are advised to take measures to protect the …show more content…

Department of Health and Human Services (DHHS) to safeguard patient privacy. It protects patients’ health information (PHI) and allows patients to have control over the distribution of their information. Due to the advancement in technology and shift from paper to electronic files, the development of both state and federal laws occurred to protect the electronic health care transactions, code sets, unique health identifiers and security (DHHS, 2016). In addition, due to e-PHI a Privacy Rule was published in December 2000, to protect health information under these entities: health plans, healthcare clearinghouses, and health care providers who conduct certain health care transactions electronically. This law implements various types of health facilities; including, hospitals, doctor offices, pharmacies, health plans, and other clinical care sites (Field, p. 199). Health Care Agency Hospitals are one of many health care agencies that HIPAA impacts. These agencies consist of health providers, consumers, and health insurance usage. There is such a strong impact between HIPAA and hospitals because of the provider to patient relationship. Also, there are ton of patient files that have private information. Therefore, the need for a data backup plan, disaster recovery plan, and critical analysis is very important.

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