Paubox blog: HIPAA compliant email made easy

How HIPAA supports health research

Written by Caitlin Anthoney | December 21, 2024

When Congress passed the Health Insurance Portability and Accountability Act (HIPAA) in 1996, it focused on the portability of health insurance and safeguarding individuals’ protected health information (PHI).

 

Congress’ vision for research and privacy

The legislators recognized that health research sometimes requires access to individually identifiable health information. Legislators wanted to guarantee that privacy protections under HIPAA would not excessively impede researchers’ access to necessary data. 

In two House Reports on HIPAA, Congress stated, “The conferees recognize that certain uses of individually identifiable information are appropriate, and do not compromise the privacy of an individual. Examples of such use of information includethe transfer of information from a health plan to an organization for the sole purpose of conducting healthcare-related research.”

“As health plans and providers continue to focus on outcomes research and innovation, it is important that the exchange and aggregated use of health care data be allowed.”

Ultimately, these reports show an appreciation that research can be conducted with integrity without violating individual privacy.

 

Designing the Privacy Rule

According to a book titled ‘Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research,’ when developing the Privacy Rule, the Department of Health and Human Services (HHS) needed to safeguard individual privacy while allowing the continued use of health information for research.

Specifically, the research states, “One option considered was exempting PHI used in research from the regulations, but HHS rejected this option, noting some reported shortcomings of the protection of the privacy and confidentiality of health information in research.”

The following approaches were considered:

Exempting research from privacy protections

One option was to exempt research-related PHI disclosures from regulation. However, HHS rejected this approach due to concerns about the adequacy of existing protections for privacy and confidentiality in research. 

 

Requiring individual authorization

HHS also considered requiring researchers to obtain individual authorization for all PHI disclosures. While this would have maximized privacy protections, it would have made many research projects, particularly large-scale or retrospective studies, impossible to conduct.

 

A balanced approach

Ultimately, HHS opted for a middle ground. The Privacy Rule allows covered entities to disclose PHI for research purposes without individual authorization under certain conditions, like when an international review board (IRB) or Privacy Board approves a waiver of authorization. 

 

Protecting privacy in research

The Privacy Rule’s allows that healthcare researchers to use:

  • Authorization waivers: IRBs or Privacy Boards can approve authorization waivers if specific criteria are met, like minimizing individuals’ privacy risk.
  • De-identification: Researchers can use de-identified data, which falls outside the scope of HIPAA’s regulations.
  • Limited data sets: Researchers also have access to restricted data sets, which remove specific direct identifiers pursuant to a data use agreement.

 

How HIPAA compliant email supports healthcare research

HIPAA compliant email solutions, like Paubox, use advanced security measures so researchers can securely share PHI, minimizing the risk of potential data breaches. It is especially useful in multi-institutional studies or when researchers coordinate with healthcare providers for data sharing, subject recruitment, or follow-ups.

Ultimately, these secure emails help researchers maintain regulatory compliance while giving them access to data that drives medical innovation. 

 

FAQs

What is HIPAA compliance?

HIPAA compliance refers to adhering to regulations outlined in the Health Insurance Portability and Accountability Act to safeguard patients’ protected health information (PHI).

 

Who does HIPAA apply to?

HIPAA applies to covered entities, which include healthcare providers, health plans, and healthcare clearinghouses. It also applies to business associates of these covered entities. These are entities that perform certain functions or activities on behalf of the covered entity.

 

What types of information can HIPAA compliant emails include?

HIPAA compliant emails can include sensitive health information, like patient education materials, appointment reminders, treatment plans, and other medical communications.