Which businesses must comply with HIPAA laws?
Any healthcare entity be it healthcare service providers, health planners, and healthcare clearinghouses that electronically process, store, transmit, or receives medical records, claims or remittances must comply with HIPAA law.
What is a Covered Entity (CE)?
Any business entity that falls in the scope of HIPAA Compliance and is expected to comply with the regulations may be called as a covered entity. This would typically include healthcare providers, insurance companies, and clearinghouses.
What is Protected Health Information (PHI)?
Information that relates to the health condition of an individual and that either identifies the individual or there is a basis to believe that the information can be used to identify, locate, or contact the individual can be called as Protected Health Information.
What are the penalties for HIPAA non-compliance?
Non-Compliance to HIPAA Regulation can result in fines up to $250,000 for violations or even imprisonment up to 10 years for knowing abuse or misuse of health information.
Does HIPAA apply to medical devices?
Any device or electronic equipment that collects, stores, or transmits PHI will fall in the scope of HIPAA. This would even include medical devices, wearable, and IoMT (Internet of Medical Things) devices that have in-built microprocessors and features WiFi/Bluetooth that can store PHI data and also transmits it to the cloud and accessed by the healthcare entity.
Does the Privacy Rule apply to de-identified health information?
No. The Privacy Rule does not apply to de-identified information since it neither identifies nor provides a reasonable basis to identify an individual.