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Health Information Privacy and Security

Originally Published MX September/October 2003

Governmental & Legal Affairs

The iron law of unintended consequences strikes again.

Mark E. Lutes 

It has happened many times before in Washington, DC--legislation intended to produce one result spawns numerous unanticipated consequences. Nonetheless, this recent story of unintended consequences arising from the regulation of the confidentiality of healthcare data is a fascinating one. It also carries serious implications and lessons for medical device manufacturers.

The legislation is the now well-publicized administrative simplification provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).1 Through administrative simplification of healthcare transactions and code sets, Congress intended to reduce the cost of processing healthcare claims submissions, claims payments, and similar transmissions.
While promoting and standardizing electronic claims administration, Congress thought that it should also mandate safeguards for its privacy and

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