Microsoft Certified Partner

 

 

Regulatory Expertise

DMAS developed Pharmaceutical Regulatory Expertise in 1999 when engaged by a publicly traded pharmaceutical manufacturing company to assist in the development and deployment of it's computer controlled manufacturing execution system within a "Class 1000" clean room. Refer to US FED STD 209E / ISO 14644

DMAS then leveraged its regulatory knowledge in 2001 when ask to participate in a joint venture specific to the Health Insurance Portability Accountability Act (HIPAA) of 1996.

DMAS developed a comprehensive suite of services and bundled product to facilitate regulatory compliance in the health care industry.

The HIPAA Privacy Rule took effect on April 14, 2003. The HIPAA Privacy Rule regulates the disclosure of information held by "covered entities" (generally, health care clearinghouses, employer sponsored health plans, health insurers, and medical service providers that engage in certain transactions.) It establishes regulations for the use and disclosure of Protected Health Information (PHI). PHI is any information held by a covered entity which concerns health status, provision of health care, or payment for health care that can be linked to an individual.

The Final Rule on Security Standards was issued on February 20, 2003. It took effect on April 21, 2003 with a compliance date of April 21, 2005 for most covered entities and April 21, 2006 for “small plans.” The Security Rule complements the Privacy Rule. While the Privacy Rule pertains to all Protected Health Information (PHI) including paper and electronic, the Security Rule deals specifically with Electronic Protected Health Information (EPHI). It lays out three types of security safeguards required for compliance: administrative, physical, and technical. For each of these types, the regulatory rules identify various security standards, and for each standard, it names both required and addressable implementation specifications. Required specifications must be adopted and administered as dictated by the Rule. Addressable specifications are more flexible.
 

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