Are pharmaceutical companies covered entities?

Pharmaceutical companies that handle protected health information, provide healthcare services, and engage in activities like drug development and clinical trials are subject to HIPAA regulations as covered entities.

What PHI do pharmaceutical companies interact with?

Pharmaceutical companies may interact with various types of PHI depending on their specific roles and activities within the healthcare ecosystem:

Clinical trial data

Medical records: Information obtained during clinical trials can include participants' medical histories, diagnoses, treatments, and outcomes.

Lab results: Data from laboratory tests conducted in the clinical trial, including blood tests, genetic testing, imaging results, etc.

Healthcare provider collaboration

Patient demographics: Names, addresses, dates of birth, and other identifying information of patients involved in collaborative healthcare programs.

Treatment information: Details about the medications prescribed or recommended by healthcare providers related to the pharmaceutical company's products.

Marketing and sales

Prescription information: Aggregated data on prescriptions filled might include patient demographics without individual identifiers.

Sales and marketing data: Information about healthcare professionals or institutions interacting with the pharmaceutical company, potentially containing patient-related information.

Go deeper: 

• HIPAA compliant email marketing: What you need to know
• 7 easy steps to include PHI in marketing emails

Pharmacovigilance and safety monitoring

Adverse event reports: Data related to adverse events associated with the use of medications, often involving patient details.

Post-market surveillance: Information collected after a drug is on the market, such as monitoring patient outcomes or any safety concerns reported by healthcare professionals.

Telehealth and digital health services:

Remote patient monitoring data: Information collected through wearable devices or remote monitoring tools that track patient health parameters, if the company is involved in such initiatives.

Teleconsultation records: Data from remote consultations or telehealth sessions, including patient information and medical discussions.

Research and development:

Genomic information: In cases where pharmaceutical companies engage in genomic research, they might handle genetic information from study participants.

Clinical data: Information from research collaborations with healthcare providers, academic institutions, or other entities involving patient health records.

Related: HIPAA PHI: Definition of PHI and List of 18 Identifiers

HIPAA compliance of pharmaceutical companies

Pharmaceutical companies often engage in activities like drug development, clinical trials, and sometimes even healthcare services. During these activities, they may collect, use, or manage protected health information (PHI) from patients or participants, making them covered entities.

Here's a breakdown of how HIPAA regulations apply to these scenarios:

• Drug development: Pharmaceutical companies might collect health information from clinical trial participants during drug development. This information could include medical histories, lab results, and other data relevant to the trial. If this includes individually identifiable health information, it's considered PHI under HIPAA.
• Clinical trials: Conducting clinical trials involves collecting and analyzing data related to participants' health. Pharmaceutical companies might gather sensitive information about individuals' health conditions, treatments, and medication responses. Any individually identifiable health information collected during these trials falls under HIPAA regulations.
• Healthcare services: Some pharmaceutical companies might also operate clinics or provide healthcare services related to their products. They may handle patient health information in these cases, subjecting them to HIPAA regulations as covered entities.