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The Health Insurance Portability and Accountability Act (HIPAA)
requires health care organizations to secure and protect the privacy of confidential
information. HIPAA calls for standard formats for electronic transactions to maintain the
confidentiality and privacy of any medical information, along with rules for medical document
security, retrieval, and verification. These standardized national requirements apply to the
electronic transmission of any patient health information, records, insurance enrollment, and
claims, etc.
Federal Regulations (21 CFR Part 11) - The FDA 21 of the Code of Federal Regulations (CFR) Part 11, issued on March, 2000, allows the use of electronic digital signatures to meet any of the record and signature requirements of the Prescription Drug Marketing Act (PDMA). In compliance with the rule, FDA-regulated companies can now use electronic digital signatures to confirm delivery of a specific package of prescription drug samples to the sample receipt information. STL’s SecureTrade DigitalPrescription (DPX) [include link] is an integrated and comprehensive electronic digital signature service providing doctors and pharmaceutical manufacturers an easy way to transfer records requiring the equivalent of ink signatures.
SecureTrade DHSX helps organizations meet HIPAA policies in a simple and secure way. With our secure electronic digital signature product (DSX), STS [is this supposed to be STL?] provides the medical industry a fast, easy-to-use solution to replace paper-based processes in a totally secure environment. STL's DSX service is compliant with HIPAA, Title 21 Code of Federal Regulations (21 CFR Part 11) Electronic Records, Electronic Signatures and documents, lists, policies, programs, and statements relating to Compliance References used by Food and Drug Administration (FDA).
For more information on HIPAA regulations, please refer
to: http://www.fda.gov/ora/compliance_ref/default.htm |