Updated on October 31, 2022
Overview:
Health Insurance Portability and Accountability Act were enacted in 1996 to ensure patient’s safety and welfare. It is a law created to ensure the protection of patients’ health information data from being revealed without the patient’s consent. HIPAA’s compliance is handled by the Department of Health and Human Services.
To carry out Clinical Research, there is a need for stringent checks on the team involved in that research study. The team involved has to go through all the training including GCP and HIPAA’s Protections For Health Information Used For Research Purposes to ensure patients’ rights are safeguarded and data secured.
What Are HIPAA Privacy Rules?
The HIPAA Privacy Rules are set by the US Department of Health and Human Services to execute the provisions of HIPAA. The HIPAA Privacy Rule oversees the use and disclosure of health information of the participants involved in the study. It is also called Protected Health Information or PHI by entities that comply with privacy rules. These individuals and organizations are popular as ”covered entities”.
One of the major objectives of the Privacy Rules is to allow individuals to understand and control how their health information is utilized. It also ensures that their health information is secured with promoting high-quality care simultaneously.
HIPAA’s Protections For Health Information Used For Research Purposes:
HIPAA Compliance:
The following needs to be HIPAA compliant.
- Covered Entities: According to HIPAA regulations, a covered entity is any business that acquires, builds, or transfers PHI electronically.
- Healthcare Providers: They are involved in electronically transmitting health information, regardless of the size of the practice.
- Health Plans: This includes health, dental, vision and prescription drugs, Medicare, Medicaid, and multi-employer health plans.
- Business Associates: As per HIPAA regulations, a business associate is any organization that comes in touch with PHI while functioning for a covered entity under an agreement. As there are so many different service providers that can manage, disseminate, or process PHI, there is plenty of examples of business associates. Billing businesses, practice management companies, third-party consultants, EHR platforms, MSPs, IT providers, and faxing companies are typical examples of business associates impacted by HIPAA regulations.
Objectives of HIPAA: HIPAA’s Protections For Health Information Used For Research Purposes:
The objectives of HIPAA are:
- Eliminate healthcare fraud and abuse
- Guarantee the security and privacy of health information
- Maintain standards for health information
Requirements of HIPAA Compliance:
All covered companies and business associates are mandated to stick to a set of federal requirements outlined in the HIPAA regulation. Some of the prerequisites are documented below:
- Self-Audits: In order to determine if their organization complies with HIPAA Privacy and Security standards on an administrative, technical, and physical level, covered entities and business partners must undertake annual audits of their business. A Security Risk Assessment is merely one crucial audit that HIPAA-beholden companies are obliged to conduct in order to maintain their compliance year after year. This means that it is not enough to be compliant with HIPAA.
- Plans for rectifying compliance violations must be set in place once covered businesses and business partners have discovered their compliance voids through these self-audits. Dates by which gaps will be sealed are needed to be included in these remediation plans, which must be thoroughly documented as per HIPAA’s Protections For Health Information Used For Research Purposes.
- Employee training and policies must be designed in conformity with HIPAA regulatory measures as defined in the HIPAA Rules by covered businesses and business associates. To take into account changes to the company, these policies and procedures must be altered on a regular basis. Along with documented employee attestation that staff has read and understood each of the organization’s rules and procedures, annual staff training on these policies and procedures is mandated.
- Documentation: HIPAA-responsible enterprises are required to keep track of each step they take to comply with the law. To pass rigorous HIPAA audits, this documentation is critical during a HIPAA investigation.
- Management of Business Associates: Both Covered Entities and Business Associates are required to keep records of all vendors with whom they exchange PHI.
- Incident Management: If a covered company or business associate has a data violation, they should have a procedure in place to register the incident and inform patients in line with the HIPAA Breach Notification Rule that their private information has been compromised.
HIPAA’s Protections For Health Information Used For Research Purposes:
HIPAA Violation:
- A lost or stolen device: The ease with which a lost or stolen device can lead to theft or unauthorized access to PHI is one of the most frequent HIPAA offenses. Healthcare professionals have sensitive information on their devices that if in case gets robbed can lead to huge losses and breaches of patient data.
- Lack of employee training: Consistent HIPAA compliance among employees is a credit to their hard work, but it is also the outcome of the training received from senior management. Unfortunately, a large number of behavioral health clinics do not adequately train their staff on HIPAA compliance. Obvious compliance issues won’t be a problem without adequate or complete HIPAA training, but employees’ ignorance of the smaller, more intricate infractions will. Unfortunately, even minor infractions can have a big impact on the practice. Practice security is maintained by being proactive and preparing staff for everything related to HIPAA compliance.
- Breaches in Database: Data hacking can be carried out in any organization. It is therefore very important to ensure strict security measures are adopted to secure patient information.
- Revealing PHI (patient health information): Recklessly exchanging patient information with non-medical practice staff members might jeopardize a patient’s right to privacy and have a negative financial impact on the office. This also goes against HIPAA’s Protections For Health Information Used For Research Purposes. Mindfulness is always good for protection.
- Inappropriate dumping of PHI: Employees should always shred or destroy patient records before discarding PHI. Simply discarding records is insufficient and makes it simple for PHI to be accessed by unauthorized parties (more so now). Additionally, if patient information or PHI were saved securely electronically on local and portable device hard drives, it’s crucial to remember to delete those locations. PHI may be protected and secured from its generation to disposal with the use of effective personnel training.
The Takeaway
HIPAA’s Protections For Health Information Used For Research Purposes is a set of rules incorporated into Clinical Research practice to ensure the safety and welfare of participants. It also ensures the integrity and safety of patients’ data. For the success of a Clinical Trial, it is vital to ensure that your organization and employees are compliant with HIPAA to provide an excellent experience to the participants of a Clinical Trial.
