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Clinical trials can maintain the integrity of the research in cases where protected health information (PHI) is not de-identified by adhering to HIPAA compliant communication practices. Clinical trials must ensure compliance with federal regulations, ultimately advancing medical knowledge and innovation while upholding ethical and legal standards.


Why is HIPAA compliant communication necessary during clinical trials?

HIPAA sets strict standards for the handling of PHI, ensuring that medical data remains confidential. Participants share sensitive health information in clinical trials, and researchers must communicate securely to protect this data.

When researchers and healthcare providers transmit trial-related documents securely, they ensure that patients' data remains confidential and is not exposed to unauthorized access or breaches.

See also: The role of patient consent in research


Documentation that should be sent by HIPAA compliant communication

The following documentation should always be shared securely and in compliance with HIPAA regulations: 

  1. Informed consent documents
  2. Authorization forms
  3. Patient records
  4. Research data
  5. Correspondence with IRBs
  6. Participant contact information
  7. Limited data sets
  8. Medical imaging and records
  9. Recruitment materials


Is HIPAA compliant communication still required if PHI is de-identified?

No, HIPAA compliant communication is not typically required if PHI has been de-identified. De-identification is a process that removes or alters specific identifiers from health information, making it extremely unlikely for an individual to be identified. In such cases, the data is no longer considered PHI and is not subject to HIPAA regulations.

De-identified health information can be shared more freely for research, policy assessment, and other purposes without the stringent privacy safeguards required for identifiable PHI. 

However, it's necessary to note that even with de-identified data, there is always a small risk of re-identification if additional information becomes available. While not mandated by HIPAA, organizations handling de-identified data may still choose to use secure and confidential communication methods to further safeguard the privacy of individuals involved in research or data-sharing endeavors.


How to ensure HIPAA compliant communication during clinical trials?

  1. Select a HIPAA compliant email service: Choose an email service provider that offers HIPAA compliant email hosting services. Verify that the provider signs a business associate agreement (BAA) to ensure they comply with HIPAA requirements.
  2. Implement secure email encryption: Enable end-to-end encryption for all email communication. This ensures that emails are encrypted both in transit and at rest, making it difficult for unauthorized individuals to access PHI.
  3. Use secure email protocols: Configure email servers to use secure protocols such as SSL/TLS to encrypt data transmission. Disable unsecured protocols like POP3 and use secure options like IMAPS for email retrieval.
  4. Enable message encryption: Use message-level encryption to protect the content of emails. Only authorized recipients with decryption keys should be able to read the message.
  5. Secure user authentication: Implement authentication methods for email access, such as two-factor authentication (2FA). This ensures that only authorized personnel can access the email system.
  6. Access control and authorization: Set up access controls to restrict email access to individuals with specific roles or permissions.
  7. Secure mobile email access: If clinical trial personnel need to access email on mobile devices, enforce strict security policies on those devices, including passcodes and device encryption. Consider implementing a Mobile Device Management (MDM) solution to manage and secure mobile devices.
  8. Phishing awareness training: Train clinical trial team members to recognize phishing attempts and email scams, which are common sources of data breaches.
  9. Email archiving and retention policies: Develop email archiving and retention policies to ensure emails containing PHI are retained for the required period and can be retrieved when needed. Ensure that email archives are also secure and compliant.
  10. Secure email attachments: Encrypt email attachments containing PHI separately from the email body. Attempt to always share decryption instructions securely with authorized recipients.


What to look for in a HIPAA compliant email solution

Here's what to look for in a HIPAA compliant email solution:

  • How is email encrypted in transit?
  • How is email encrypted at rest?
  • Will each vendor that processes or handles PHI in email sign a business associate agreement with your organization?
  • As a best practice, is the HIPAA compliant email solution HITRUST CSF certified?

See also: How to send HIPAA compliant emails

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