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:
HIPAA Regulation:
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.
HL7 Standardisation:
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