HIPAA compliant email during clinical trials

HIPAA compliant communication practices make sure that clinical trials maintain the integrity of the research when protected health information (PHI) is not de-identified. It also ensures 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?

Research published in Patient Education and Counseling has shown that communication interventions applied in clinical settings can improve physician and patient behaviors in beneficial ways:

“Research linking communication to improved health outcomes typically falls into two categories. First, a number of RCTs have examined the effects of interventions designed to alter clinician and patient communication and decision-making in medical encounters...demonstrated that communication interventions generally promoted physician and/or patient communication behaviors thought to be desirable and effective.”

Patients tend to ask more questions, and physicians provide more thorough information. This leads to better adherence to treatment plans, higher patient satisfaction, and ultimately, more favorable health outcomes. 

HIPAA fits into this scenario by protecting the privacy and security of patient information exchanged during these communications. It assures that any personal health information shared in the context of clinical trials is protected. 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

FAQs

Can researchers use email to recruit participants for clinical trials?

Yes, researchers can use email for recruitment purposes.

How do HIPAA rules change when emailing international participants in a clinical trial?

HIPAA rules apply within the United States. However, when emailing international participants, it's necessary to comply with local data protection laws (like GDPR in Europe) in addition to maintaining HIPAA for any data that is handled or stored in the U.S.

Are there specific encryption standards required for emails containing PHI in clinical trials?

HIPAA does not specify exact encryption standards but requires the use of an encryption method that meets NIST (National Institute of Standards and Technology) guidelines to ensure the confidentiality and integrity of PHI such as TLS 1,2 and higher.