HIPAA

The Health Insurance Portability and Accountability Act (HIPAA), is a federal law passed by US Congress in 1996 that requires the establishment of national standards for electronic transactions, privacy, and security of healthcare information. HIPAA (45 CFR Parts 160 and 164) applies to all covered entities (CEs), e.g., health care providers, health plans, and health care clearing houses, and its privacy and security regulations have a significant impact on the conduct of clinical trials by life science organizations and healthcare providers. It establishes the conditions under which electronic protected health information (ePHI) may be used or disclosed by covered entities for research purposes. The regulations require covered entities to take reasonable steps to limit the use or disclosure of, and requests for, protected health information to the minimum necessary to accomplish the intended purpose.

Failure of a healthcare provider, CRO or investigator to comply with HIPAA regulations and adequately protect sensitive data can face time-consuming insurability issues, patient misdiagnosis problems, civil lawsuits, criminal penalties, embarrassment and loss of credibility.

Capabilities

The PharmaSys staff can perform HIPAA training, audits and the development of required policies and procedures. Our staff is well versed in the security of electronic databases and are familiar with data management in regulated industries. See our Computer Validation services page for additional information.

If you are interested in finding out more about PharmaSys' world-class offerings, complete and submit the form provided below. You will be contacted to discuss your needs and provided with information about how PharmaSys can help you achieve your compliance and validation goals.