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FDA/DEA Regulatory Compliance: EPCS
Thales e-Security’s Data Security Platforms can secure the data associated with EPCS applications and is available as a FIPS 140-2 Level 2 or Level 3 validated appliance.

Complying with Electronic Prescriptions for Controlled Substances (EPCS) Requirements
Regulation
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Thales e-Security’s Data Security Platforms can secure the data associated with EPCS applications and is available as a FIPS 140-2 Level 2 or Level 3 validated appliance.
"Electronic Prescriptions for Controlled Substances" revises DEA's regulations to provide practitioners with the option of writing prescriptions for controlled substances electronically. The regulations will also permit pharmacies to receive, dispense, and archive electronic prescriptions.
The DEA’s requirements for EPCS include:
In addition, in “§1311.205 Pharmacy application requirements” in the same DEA publication, the section states:
Make your data unreadable to others through strong, centrally managed, file, volume and application encryption combined with simple, centralized key management that is transparent to processes, applications and users.
Restrict access to encrypted data through access policies and user controls that permit data to be decrypted only for authorized users and applications, while allowing privileged users to perform IT operations without the ability to see protected information.
Logs that capture access attempts to protected data provide high value security intelligence information that can be used with a Security Information and Event Management (SIEM) solution and for compliance reporting.
The Vormetric Data Security Platform makes it efficient to manage data-at-rest security across your entire organization. Built on an extensible infrastructure, Vormetric Data Security Platform products can be deployed individually, while sharing efficient, centralized key management...
Mandate
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Since June 5, 2014 federal agencies have been required to meet FedRAMP standards, ensuring they meet internal data security standards and extended security controls for cloud-computing.
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These regulations cover healthcare information in the US, HIPAA relates to protection; encryption, key management. etc and HITECH relates to disclosure of data breaches.
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United States Federal Law setting standards for a range of US companies, SOX Act sections 302 and 404 relate directly to data protection.
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