FDA/DEA Regulatory Compliance: EPCS

Complying with Electronic Prescriptions for Controlled Substances (EPCS) Requirements

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FDA/DEA Regulatory Compliance: 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.

Thales eSecurity can help prepare organizations to meet these regulations through:

  • FIPS-certified protection of private keys;
  • Industry-leading experience in designing and implementing PKI solutions;
  • A secure execution environment for running sensitive cryptographic processes.
FDA/DEA Regulatory Compliance: EPCS
The DEA's EPCS Regulation

"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:

  • (16) The digital signature functionality must meet the following requirements:
  • (i) The cryptographic module used to digitally sign the data elements required by part 1306 of this chapter must be at least FIPS 140–2 Security Level 1 validated. FIPS 140–2 is incorporated by reference in Section 1311.08.
  • ....
  • (iii) The electronic prescription application's private key must be stored encrypted on a FIPS 140–2 Security Level 1 or higher validated cryptographic module using a FIPS-approved encryption algorithm. FIPS 140–2 is incorporated by reference in Section 1311.08.

In addition, in “§1311.205 Pharmacy application requirements” in the same DEA publication, the section states:

  • (b) The pharmacy application must meet the following requirements:
  • (4) For pharmacy applications that digitally sign prescription records upon receipt, the digital signature functionality must meet the following requirements:
  • (i) The cryptographic module used to digitally sign the data elements required by part 1306 of this chapter must be at least FIPS 140–2 Security Level 1 validated. FIPS 140–2 is incorporated by reference in Section 1311.08.
  • ....
  • (iii) The pharmacy application's private key must be stored encrypted on a FIPS 140–2 Security Level 1 or higher validated cryptographic module using a FIPS-approved encryption algorithm. FIPS 140–2 is incorporated by reference in Section 1311.08.
Encryption and Key Management

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Access Policies and Privileged User Controls

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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

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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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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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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

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.

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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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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 our payment security platforms, protecting encryption keys from virtually any attack. This helps Verifone to continue reducing merchants’ growing exposure to data breaches and cyber criminals and more aggressively safeguard consumer information… Joe Majka,Chief Security Officer

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