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This page contains information on the following recent Federal security regulations:
HIPAA
NRC Regulations Regarding SGI
FDA 21-CRF-Part 11
HIPAA
The
Health Insurance Portability and Accountability Act (HIPAA), enacted
into law by Congress in 1996, contains regulations
regarding the handling of protected health
information (PHI).
Compliance with HIPAA guidelines on patient privacy (the Privacy
Rule) became mandatory on April 14, 2003.
ISC helps covered organizations
(health care providers, health plans, health care and insurance
clearinghouses,
etc.) safeguard their sensitive electronic health information.
Our products can be used to securely store, maintain, and
transmit PHI. When used properly, encryption and certificates
(also known as "digital IDs") provide effective means
of limiting access to PHI to authorized health care professionals.
Reference: NIST Special Publication 800-66, An Introductory Resource Guide for Implementing the Health Insurance Portability and Accountability Act (HIPAA) Security Rule, U.S. Department of Commerce, March 2005.
ISC Solutions Addressing HIPAA Requirements
Authentication |
CertAgent X.509
certificate management system
CDK cryptographic
libraries |
Access Control |
CertAgent X.509
certificate management system
CDK cryptographic
libraries |
Data Integrity and Confidentiality |
SecretAgent encryption and digital signature software
SpyProof! encrypted
virtual disk partitions
CertAgent X.509
certificate management system
CDK cryptographic
libraries |
| Data Transmission Security |
SecretAgent encryption
and digital signature software
CertAgent X.509
certificate management system
CDK cryptographic
libraries |
| Audit Trails |
SecretAgent and CertAgent offer extensive logging and reporting
facilities to track all security-related operations |
How SecretAgent Can Help Address HIPAA Requirements
SecretAgent allows
covered organizations to securely exchange PHI via e-mail or other
file transfer mechanisms (FTP, HTTP, etc.).
SecretAgent supports all federally-approved security protocols
for file encryption and is based on ISC's FIPS
140-1 validated cryptographic engine. Interoperable versions
of SecretAgent are available on all popular computing platforms.
SecretAgent is extremely economical for secure data transfers
in a single direction, such as from a hospital to an insurance
clearinghouse. Only the sending entity needs to purchase a SecretAgent
license; the receiving party can use the free SA5Reader application
to decrypt incoming data. (A key pair can be generated
for the receiving party by the sender, or the receiver can purchase
an X.509 certificate from ISC for a nominal fee, currently
$10/yr.)
Related Information
HIPAA is interpreted and enforced
by the Department of Health and Human Services' Office
of Civil Rights, and the Centers
for Medicare & Medicaid Services. An HHS
website devoted
to Privacy
and Security matters and providing links to final Privacy Rules
published in the Federal Register is here.
NRC Regulations Regarding SGI
At the end of 2004 the US Nuclear Regulatory Commission published an immediately effective order and a proposed rule that affects “All Licensees Who Possess Radioactive Material in Quantities of Concern and All Other Persons Who Obtain Safeguards Information.” These new regulations impose strict requirements on the protection of information that concerns the safeguarding of radioactive materials.
For information regarding the secure handling of SGI and SGI-M information using ISC products, vist:

FDA 21-CRF-Part 11
For information on compliance with the FDA's 21 CRF Part 11 rule, visit:

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