Medical Devices and HIPAA (Health Insurance Portability and Accountability Act) A Basic Introduction in plain English

It became federal law on August 21, 1996 and will become compliant mandatory on April 14th, 2005. This federal standard is stirring up a big buzz across the nation as hospitals burn the midnight oil to meet compliance.

How does "Insurance" make it's way into the "I" in "HIPAA". We won't get into the history too deep here but note that it stems from insurance reform. In short – HIPAA was developed by the US's department of Health and Human Services (HHS) and stemmed from the desire to standardize the electronic transfer of data. In essence the Insurance industry was suffering from a lack of norm when it came to medical transaction and billing data.

For those of us who work in the Hospital Information System (HIS) industry the work HIPAA has become an everyday word for protecting confidentiality and ensuring information security, as well as providing an overall improvement to the quality of data.

HIPAA Scope

The main focus of HIPAA is entirely on Health Information. The scope is not exclusively for products but services as well. What does Health Information consist of?

HEALTH INFORMATION- The term `health information' means any information, whether oral or recorded in any form or medium, that--

(A) is created or received by a health care provider, health plan, public health authority, employer, life insurer, school or university, or health care clearinghouse; and

(B) relates to the past, present, or future physical or mental health or condition of an individual, the provision of health care to an individual, or the past, present, or future payment for the provision of health care to an individual.

This essentially covers most if not all information related to health that applies to an individual. This includes any information that applies to a person’s physical, mental, or functional condition – these would all require HIPAA. Non health care services do not (under the definition of HIPAA) require compliance with the standard.

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