Health IT

Business Associate’s Agreements between Covered Entities and Business Associates Click here to purchase a standard Business Associate’s Agreement in compliance with 45 C.F.R. section 164.314(a).

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A Brief History of HIPAA, ARRA and HiTech

A brief history lesson on HIPAA, ARRA and HiTech:

  • In 1996, HIPAA empowered the Secretary of Health and Human Services (HHS) to issue regulations that would address the privacy and security of health data.
  • In 1998, HHS issued its first draft of the regulations implementing administrative, technical and physical safeguard requirements for electronic protected health information.
  • In 2003, HHS issued its final security regulations, which gave about two years for covered entities to come into compliance.
  • In 2005, HHS promulgated enforcement regulations, giving CMS authority to audit covered entities for security regulations compliance.
  • In 2009, ARRA expanded applicability of the security regulations to business associates of covered entities.
  • At the end of 2009, HHS issued draft regulations to define “meaningful use” within the context of ARRA.  Among the proposed requirements for Stage 1 of meaningful use is compliance with the security regulations, specifically performing a risk assessment as required within section 164.308(a)(1) of the security regulations, and implement appropriate mitigations.  This requirement under meaningful use is in the draft regulations at section 495.6(c)(17).
  • Stage 1 meaningful use requirements became a final rule in 2010.  Drafts of Stage 2 and Stage 3 meaningful use are now on the drawing board.
  • Starting in 2011, providers become eligible for receiving incentive payments under the Medicare or Medicaid program for those that can demonstrate they are “meaningful EHR users” of a certified electronic health records system.
  • In future years, providers must continue to demonstrate that they are meaningful EHR users as that phrase is defined in section 495.6 in future, final rules.
  • For Medicare providers that have not adopted a certified EHR by 2015, Medicare will start to reduce base compensation as a penalty for not adopting EHR.

HHS is then supposed to issue regulations that define Stage 2 and Stage 3 “meaningful use,” beyond the basics (and likely in addition to) the final requirements for Stage 1 compliance.  Providers will need to be able to demonstrate compliance with these additional requirements to receive further incentive payments under ARRA.

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