I thought it was important to understand Health Care conformance issues by the US
Government and how they effect Software.
This is by no means intended to be a comprehensive list.
Developing Software which is used in the US must conform to guidelines set forth by US Dept HHS.
These standards are:
1)Any Health Insurance/Claims Software must protect patients confidentiality in conformance with HIPAA Regulation Act
This act came about after an individual was dismissed from his position after a secretary (who was privy to the individuals medical condition) told her boss that the individual had cancer and was going to cost the company alot of money..A public outcry caused passage of the Health Insurance Portability and Accountability Act which was signed by President Clinton in 1996. This regulation speaks of the information one is allowed to disclose and the authorisation procedure to protect the patient's medical information, To learn more I encourage you to visit the website
HIPAA Law Explained
It is vitally important that you read and understand this law before your software disseminates any information on any patient.
2)Medical information which is exchanged with any provider should now conform to a known set of message interchange formats called HL7. When you consider that each medical facility in the US contains Terabytes of Paient and Clinical information the need for organising the data in a logical, robust and extensible controlled manner becomes readily self-evident. In short HL7 is a messaging format which is encoded using eXtensible Markup Language This standard is extensible in that it takes into account every aspect of the patient visit including Admit, Discharge, Transfer as well as Patient Demographics. Also included in the HL7 Standard Format are provisions for HCFA Medical Necessity requirement for outpatient services. Also included are standardised formats for Patient Accounting and Charges. I encourage you to visit the HL7 site to gain an in-depth understanding of HL7 Standards at HL7 Standards Explained
CFR Part11 (Medical Signature)
3)As more and more data charts, graphs as well as patient records are scanned in to Hospital Databases it has become necessary for those records to convey proper identification by authorised medical personnel. The standard adopted to identify medical signatures is called FDA CFR (Code of Federal Regulations) Part 11. A common scenario could be a diagnostic test which should not be implemented without identifying a signature indicating the proper medical authority acting on the behalf of his/her patient requesting that test. In order to more fully understand CFR Part 11 standard I encourage you to visit the FDA Site located at
FDA Part 11 for Medical Signature backgrounder