Health Insurance Portability and Accountability Act

The HIPAA privacy rule protects Personal Identifiable health information (PHI) and medical records. HIPAA rules are applicable to covered entities, including healthcare providers, health plans, and healthcare clearinghouses in case they transmit information in electronic form. However, HIPAA does not cover medical devices and pharmaceutical companies. Even though HIPAA does not apply directly, manufacturers are fortified to follow best practices in order to protect the privacy and security of PHI which is in their control. Therefore, manufacturers must use deidentified information instead of PHI. The non-compliance with HIPAA leads to serious consequences. In the first five months of 2017, nine legal cases were filed by Health and Human Services Office for Civil Rights (OCR) for HIPAA defilements which lead to a fine of million dollars.

Categories: Regulations

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