Privacy and Confidentiality in Clinical Research

Review statutes and regulations governing privacy and confidentiality of patient information in clinical trials involving drugs, medical devices, and other life sciences products. Counsel your healthcare organization clients on the Health Insurance Portability and Accountability Act (HIPAA), federal Common Rule, and Food and Drug Administration (FDA) regulations, which set the standards for maintaining the privacy and confidentiality of data obtained from participants in clinical trials.

Read now »

Related Content

• HIPAA Authorization to Use and Disclose PHI in Clinical Research
  Adopt this HIPAA authorization for use when a clinician or researcher anticipates disclosing an individual's protected health information (PHI) in the course of conducting research or as a result of collecting such data during clinical research. Obtain authorizations before: (1) disclosing PHI to a third party other than for treatment, payment, or healthcare operations; (2) using PHI for marketing or fundraising reasons; and (3) providing PHI to a research organization.
• HIPAA Data Use Agreement
  Employ this template data use agreement for all exchanges of PHI between a covered entity subject to HIPAA and a third-party researcher to whom the covered entity may disclose a limited data set for research, public health, or healthcare operations. Understand how the HIPAA Privacy Rule, which typically requires that covered entities meet certain conditions to use or disclose PHI for research purposes, permits a covered entity to enter into a data use agreement to use or disclose a limited data set when obtaining authorization of the research participant is not possible or practical.
• Clinical Research State Law Survey
  Rely on this state law survey to understand state rules and regulations on clinical trial coverage, including mandatory insurer coverage, protected patient populations, access to or “right to try” clinical trial programs, and informed consent and confidentiality requirements.

Practical Guidance Updates
Featuring the latest updates from your Practical Guidance account.   

• Explore the Practical Guidance Journal Spring 2024 Edition, featuring guidance on protecting attorney-client privilege and work product in a generative AI world, using AI to manage the attorney client relationship, an overview of privacy regulations in the United States, and a primer on the new Corporate Transparency Act requirements.
• For related Practical Guidance content on important recent trends, please review these easy-to-use Resource Kits on a variety of emerging topics:
  • Healthcare Fraud and Abuse Compliance Resource Kit
  • Healthcare Fundamentals Resource Kit
  • Healthcare Transactions, Licensing, and Regulation Resource Kit
  • Health Information Privacy and Security Resource Kit
• Generative Artificial Intelligence (AI) Resource Kit is a frequently updated collection of current Practical Guidance materials on generative AI, ChatGPT, and similar tools.
• Public Interest, Pro Bono, and Non-Profit Resource Kit offers valuable guidance for those providing pro bono legal services and assisting non-profit organizations and public interest groups. It includes useful content on topics including tenant's rights, fair housing and lending, discrimination, immigration, and general non-profit resources. 
• Listen Up! The Practical Guidance and Law360 Podcasts Resource Kit features interviews with industry-leading attorneys on cutting edge issues in the law: NFTs, Cannabis, COVID-19, and more.
• Legal Developments provide the latest updates and analyses of emerging topics impacting your practice area. Visit the Legal Developments page to see the latest topics, which also include breaking legal news and related Practical Guidance content.
• Learn about the 2000+ leading attorney authors contributing to our 26 practice areas in the Practical Guidance Author Center. Interested in becoming a Practical Guidance author? Click here for details. Practical Guidance is committed to amplifying diverse voices of attorneys across all differences, including gender and race.
• Document alerts allow you to stay current on legal developments that affect your practice. Find out how to set up your document alerts.

PRACTICAL GUIDANCE CUSTOMER EMAIL EDITION ON THE WEB

Experience results today with practical guidance, legal research, and data-driven insights—all in one place.

Experience Lexis+