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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Related Solutions

EPCS

EPCS revises DEA’s regulations to provide practitioners with the option of writing prescriptions for controlled substances electronically as well as receiving, dispensing and archiving electronic prescriptions. The electronic prescription application must incorporate a secure process for practitioner authentication.

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HIPAA/HITECH

The HIPAA Security Rule requires healthcare organizations to use appropriate safeguards to ensure that electronic protected health information (ePHI) remains secure while the HITECH Act requires the timely disclosure of data breaches.

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Data Residency

There are more than 100 national data privacy laws on the books. Global enterprise, SaaS vendors and cloud-solution providers need to be aware how to meet data residency requirements in their environment.

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As a global payment solutions and commerce enablement leader, Verifone’s strategy is to develop and deploy “best in class” payment solutions and services that meet or exceed global security standards and help our clients securely accept electronic payments across all channels of commerce. We selected Thales HSMs to provide robust security, unmatched performance and superior scalability across… Joe Majka,Chief Security Officer
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There is absolutely no noticeable impact on the performance or usability of applications. I am very excited at how easy the solution is to deploy and it has always performed flawlessly. Christian MuusDirector of Security for Teleperformance EMEA
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Vormetric Encryption delivers what we need it to do – without any fuss or drama – knowing it’s in place is one less thing to worry about. Albert AvilaBusiness Solutions Specialist, Fujitsu America, Inc.
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