Pharmacists are no exception to the data protection standards set by HIPAA. They must understand how HIPAA applies to them and how to uphold patient privacy to ensure data security within their pharmacy practice.
Do pharmacists need to be HIPAA compliant?
Yes, pharmacists and pharmacy professionals do need to be HIPAA compliant. They fall under the category of covered entities due to the data they deal with. This includes a wide range of patient-related information, such as patients' prescription records, medication histories, dosage instructions, medical conditions, allergies, lab results, and contact information.
Covered entities are defined under HIPAA as individuals or organizations that handle protected health information (PHI) as part of their healthcare operations.
See also: What are HIPAA's Privacy Rule provisions?
Steps to remaining HIPAA compliant within a pharmacy
Secure data access: Implement role-based access controls to limit employee access to PHI based on job responsibilities. Ensure that employees can only access the minimum necessary information required to perform their tasks.
Encryption for electronic communication: Encrypt all electronic communications containing PHI, including making use of HIPAA compliant email, to prevent unauthorized interception and access.
Secure prescription pick-up: Ensure that prescriptions are handed over securely to the correct patient. Implement a verification process that includes confirming patient identity and requiring a signature upon pick-up.
Privacy screens and counseling areas: Set up privacy screens and designated counseling areas within the pharmacy to ensure that patient consultations are confidential and not overheard by others.
Vendor management: If using third-party vendors for services like electronic health records or prescription processing, ensure they sign business associate agreements (BAAs) to commit to HIPAA compliance.
Secure document disposal: Establish proper procedures for shredding or securely disposing of paper documents containing PHI to prevent unauthorized access to sensitive information.
Physical security measures: Implement security cameras, access control systems, and alarm systems to protect against unauthorized access to the pharmacy's physical premises and storage areas.
Other legislation to be aware of
Health Information Technology for Economic and Clinical Health (HITECH) Act
This federal law, enacted as part of the American Recovery and Reinvestment Act of 2009, aims to promote the adoption of electronic health records (EHR) and strengthen HIPAA's privacy and security provisions. It extends HIPAA requirements to business associates of covered entities and introduces breach notification requirements.
Drug Supply Chain Security Act (DSCSA)
While not directly focused on data privacy, the DSCSA sets requirements for securing the pharmaceutical supply chain and includes provisions related to tracking and tracing prescription drugs to prevent counterfeiting and ensure patient safety.
Federal Food, Drug, and Cosmetic Act (FD&C Act)
This law, enforced by the Food and Drug Administration (FDA), includes provisions related to the labeling, safety, and security of prescription drugs, which can have implications for data privacy and security in pharmacy operations.
See also: How a business associate data breach impacts a covered entity
Kirsten Peremore
