FDA/DEA Regulatory Compliance: CSOS

Complying with Controlled Substance Ordering System (CSOS) Requirements

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Regulation

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FDA/DEA Regulatory Compliance: CSOS

DEA's CSOS program allows for secure electronic controlled substances orders without the supporting paper DEA Form 222. Using a public key infrastructure (PKI), CSOS requires that each individual purchaser enroll with DEA to acquire a CSOS digital certificate.

Thales eSecurity can help prepare organizations to comply with the CSOS program requirements with:

  • FIPS-certified protection of private keys;
  • Industry-leading experience in designing and implementing PKI solutions.
FDA/DEA Regulatory Compliance: CSOS
The DEA's CSOS Regulation

The DEA's Controlled Substance Ordering System (CSOS) allows for secure electronic transmission of Schedule I-V controlled substance orders without the supporting paper Form 222.

The DEA requires that auditors validate that the cryptographic modules are FIPS 140-2 certified. Auditors must also validate all aspects of the software that are addressed in the regulations.

Encryption and Key Management

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.

Access Policies and Privileged User Controls

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.

Security Intelligence

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.

Data Sheets : Vormetric Data Security Platform

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...

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Other key data protection and security regulations

NIST 800-53 / FedRAMP

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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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HIPAA

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Regulation

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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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SOX

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Regulation

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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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