Development

Do clinical trial recruitment websites need to be HIPPA compliant?

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Last edit: January 10, 2023
(11 months ago)

Development

Do clinical trial recruitment websites need to be HIPPA compliant?

Q:

We are in the process of developing a new clinical trial recruitment website, and we wanted to know if we should have HIPPA compliance in mind as we build. Do clinical trial websites for recruitment need to meet HIPPA compliance guidelines?

Issue

The client wants to know if their clinical trial website, which will be used for patient recruitment, should be HIPPA compliant.

Possible solution

Yes, clinical trial recruitment websites need to be HIPAA compliant.

According to the U.S. Department of Health and Human Services Office for Civil Rights (OCR), health care organizations must protect patients’ protected health information (PHI) even if they are participating in research or clinical trials.

This means that any website used to recruit potential study participants, as well as all associated data collection platforms, needs to follow strict HIPAA guidelines and safeguards when dealing with PHI from their prospective recruits/participants – including using secure encryption protocols for data transmitted over the internet or other networks whenever possible; ensuring access controls are put into place so only authorized personnel can view or use personal information; notifying affected individuals upon a breach involving their protected health information, and other specific requirements.

The HIPAA Privacy Rule is designed to protect the privacy of personal health information.

Clinical research is an important part of medical care. To ensure the privacy and security of patient medical information, researchers must adhere to the HIPAA Privacy Rule standards when using or disclosing PHI for research activities.

The HIPAA Rules affect clinical research by requiring entities to protect and secure identifiable human data which includes names, addresses, phone numbers, email addresses, social security numbers, medical record numbers and more. All 18 identifiers listed must be secured in order for the rules to be followed correctly.

Additional reading

  • This article discusses the challenges to subject recruitment in prospective, clinical research studies related specifically to the Health Insurance Portability and Accountability Act (HIPAA) Privacy rule as well as HIPAA compliant strategies for facilitating enhanced subject recruitment and retention. These include preparations reviews, pre-screening of potential subjects, minimizing subject burden during consent processes; enhancing follow up of subjects; utilizing clinical collaborators/staff liaisons; aiding future study recruitments with streamlined compliance training for research staffs.
  • The HIPAA Privacy Rule is a federal regulation that establishes national standards to protect individuals’ medical records and other health information (defined as “protected health information”). It requires appropriate safeguards, sets limits on the uses and disclosures of such information, gives individuals rights over their protected health information, including examination and copies. These rules have been revised several times since 1999 in order to improve coordinated care for patients. The combined regulation text of all Administrative Simplification Regulations related to HIPAA can be found at 45 CFR 160 – 164. In addition there are other notices related to these regulations issued by the Department of Health Human Services which includes statements about delegation for authority.
  • Explore the NIH notes on HIPPA compliance for Research and Frequently Asked Questions about Privacy in Research, Clinical Trials, and Healthcare  – NIH and Privacy

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