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Ensuring the usability of health IT products (1)
Certified applications to prescribe controlled substances electronically.
Use of an EPCS-certified application is the first step toward filling or prescribing controlled substances electronically. U.S. federal regulations require that all EPCS must be processed by approved applications per the Drug Enforcement Administration (DEA). An increasing number of states are passing legislation to mandate the electronic prescribing of controlled substances. UL Solutions’ staff of experts can help you to navigate the individual regulatory requirements of each state.
The DEA mandates that applications used for prescribing or filling EPCS meet all the requirements stated in 21 CFR Part 1311 Subpart C. These requirements include the use of cryptographic digital signatures, two-factor authentication and Federal Information Processing Standard (FIPS) 140-2 validated cryptographic modules.
Products are certified for a period of two years from the date of certificate issuance. Pharmacies and prescribers must also complete an audit to address processing integrity (prevention of insider threats and outsider attacks).
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Ensuring the usability of health IT products (1)
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