Medical writers are not directly bound by the Health Insurance Portability and Accountability Act (HIPAA) unless they work for a covered entity or a business associate.
The rise of medical writers
The demand for medical writers has surged in recent years due to the growing need for clear, accurate, and accessible healthcare content. Between July and December 2022, 58.5% of adults used the Internet to search for health or medical information, with women doing so more frequently than men. This increase in digital health literacy has driven a higher demand for reliable medical content, making medical writers essential in translating complex scientific information into understandable formats for various audiences.
Understanding HIPAA and its scope
HIPAA is a U.S. federal law designed to protect sensitive patient health information from unauthorized access and misuse. It applies to covered entities, including healthcare providers, health plans, and healthcare clearinghouses, as well as business associates, which handle protected health information (PHI) on behalf of covered entities.
Since medical writers often work with healthcare-related content, the question arises: Does HIPAA apply to them?
Read also: Understanding and implementing HIPAA rules
When must medical writers comply with HIPAA?
Medical writers may be bound by HIPAA if they:
- Work for a covered entity or business associate: If a medical writer is employed by or contracted by a healthcare provider, pharmaceutical company, or medical device company that directly handles PHI, they may be required to comply with HIPAA regulations.
- Handle protected health information (PHI): If a medical writer accesses patient records, case reports, clinical trial data with patient identifiers, or any other PHI, they must follow HIPAA Privacy and Security rules.
Related: How to know if your services are covered by HIPAA
When HIPAA does not apply to medical writers
In many cases, medical writers are not bound by HIPAA because:
- They typically work with de-identified data, meaning patient information has been stripped of identifying details.
- Their work often involves summarizing scientific research, regulatory documentation, or marketing content, which does not contain PHI.
- They are not directly hired by covered entities or business associates.
Best practices for medical writers to maintain compliance
Even if HIPAA does not legally apply, medical writers should adopt best practices to ensure data privacy and ethical standards, including:
- Avoiding PHI unless explicitly required for a project.
- Using de-identified data when writing case reports or clinical summaries.
- Signing confidentiality agreements to protect sensitive information.
- Storing and transmitting data securely to prevent unauthorized access.
See also: HIPAA Compliant Email: The Definitive Guide
FAQS
What qualifies as PHI in medical writing?
PHI includes any identifiable patient data, such as names, addresses, phone numbers, Social Security numbers, and medical records linked to a specific individual.
Are international medical writers subject to HIPAA regulations?
HIPAA applies to U.S.-based covered entities and their business associates. However, international medical writers working with U.S. healthcare clients may need to follow HIPAA guidelines if they handle PHI.
What legal consequences can medical writers face for HIPAA violations?
HIPAA violations can result in fines and legal penalties if a medical writer improperly handles PHI. The severity of the penalty depends on the extent of the violation and whether it was intentional or accidental.
Tshedimoso Makhene
