E9-31216 TOC
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Revision as of 22:03, 27 January 2010 by DavidWhitten (talk | contribs) (→1. Definition of Standard)
Contents
- 1 Table of Contents
- 1.1 I. Background
- 1.1.1 A. ONC Background
- 1.1.2 B. Interdependencies With Other HITECH Provisions and Relationship to Other Regulatory Requirements and Related Activities
- 1.1.2.1 1. Medicare and Medicaid EHR Incentive Programs Proposed Rule
- 1.1.2.2 2. Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule Accounting of Disclosures Regulation
- 1.1.2.3 3. Previous Recognition of Certification Bodies and New Authority Under the HITECH Act
- 1.1.2.4 4. Other HHS Regulatory Actions
- 1.1.3 C. Standards, Implementation Specifications, and Certification Criteria Processes Before and After the HITECH Act
- 1.1.4 D. Future Updates to Standards, Implementation Specifications, and Certification Criteria
- 1.2 II. Overview of the Interim Final Rule
- 1.3 III. Section-By-Section Description of the Interim Final Rule
- 1.3.1 A. Applicability
- 1.3.2 B. Definitions
- 1.3.2.1 1. Definition of Standard
- 1.3.2.2 2. Definition of Implementation Specification
- 1.3.2.3 3. Definition of Certification Criteria
- 1.3.2.4 4. Definition of Qualified Electronic Health Record (EHR)
- 1.3.2.5 5. Definition of EHR Module
- 1.3.2.6 6. Definition of Complete EHR
- 1.3.2.7 7. Definition of Certified EHR Technology
- 1.3.2.8 8. Definition of Disclosure
- 1.3.3 C. Initial Set of Standards, Implementation Specifications, and Certification Criteria
- 1.3.3.1 1. Adopted Certification Criteria
- 1.3.3.2 2. Adopted Standards
- 1.3.3.2.1 a. Transport Standards
- 1.3.3.2.2 b. Content Exchange and Vocabulary Standards
- 1.3.3.2.2.1 i. Patient Summary Record
- 1.3.3.2.2.2 ii. Drug Formulary Check
- 1.3.3.2.2.3 iii. Electronic Prescribing
- 1.3.3.2.2.4 iv. Administrative Transactions
- 1.3.3.2.2.5 v. Quality Reporting
- 1.3.3.2.2.6 vi. Submission of Lab Results to Public Health Agencies
- 1.3.3.2.2.7 vii. Submission to Public Health Agencies for Surveillance or Reporting
- 1.3.3.2.2.8 viii. Submission to Immunization Registries
- 1.3.3.2.2.9 ix. Table 2A
- 1.3.3.2.3 c. Privacy and Security Standards
- 1.3.3.3 3. Adopted Implementation Specifications
- 1.3.3.4 4. Additional Considerations, Clarifications, and Requests for Public Comments
- 1.4 IV. Collection of Information Requirements
- 1.5 V. Regulatory Impact Analysis
- 1.1 I. Background
Table of Contents
I. Background
A. ONC Background
B. Interdependencies With Other HITECH Provisions and Relationship to Other Regulatory Requirements and Related Activities
B. Interdependencies With Other HITECH Provisions and Relationship to Other Regulatory Requirements and Related Activities
The HITECH Act creates multiple interdependencies between this interim final rule and other regulatory requirements, processes, and programs.
1. Medicare and Medicaid EHR Incentive Programs Proposed Rule
2. Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule Accounting of Disclosures Regulation
3. Previous Recognition of Certification Bodies and New Authority Under the HITECH Act
4. Other HHS Regulatory Actions
Other HHS Regulatory Actions
a. Health Insurance Portability and Accountability Act of 1996 (HIPAA) Transactions and Code Sets Standards
b. Electronic Prescribing Standards
C. Standards, Implementation Specifications, and Certification Criteria Processes Before and After the HITECH Act
1. ONC’s Processes Prior to the HITECH Act
2. HITECH Act Requirements for the Adoption of Standards, Implementation Specifications, and Certification Criteria
D. Future Updates to Standards, Implementation Specifications, and Certification Criteria
II. Overview of the Interim Final Rule
III. Section-By-Section Description of the Interim Final Rule
A. Applicability
A. Applicability--Sec. 170.101
This part establishes the applicable standards, implementation specifications, and certification criteria that must be used to test and certify HIT.
B. Definitions
1. Definition of Standard
1. Definition of Standard
The term standard is used in many different contexts and for many different purposes.
The HITECH Act did not define or provide a description of the term, standard, or how it should be used in relation to HIT.
As a result, we looked to other sources to inform our definition for the term.
As specified in the HIPAA Rules, standard is defined at 45 CFR 160.103 to mean ``a rule, condition, or requirement:
- (1) Describing the following information for products, systems, services or practices:
- (i) Classification of components.
- (ii) Specification of materials, performance, or operations; or
- (iii) Delineation of procedures; or
- (2) With respect to the privacy of individually identifiable health information.``
This definition includes important concepts that we believe are applicable and appropriate for this interim final rule and we have included these concepts in our definition of standard.
Other definitions or descriptions of the term standard include
- ``an established policy on a particular practice or method;``
- ``a set of instructions for performing operations or functions;`` or
- ``a published statement on a topic specifying the characteristics, usually measurable, that must be satisfied or achieved to comply with the standard.
\2\
FOOTNOTE:
\2\ This last definition is referenced in Federal Information
Processing Standards 201.
We believe the types of standards envisioned by Congress in the HITECH Act that would be most applicable to HIT are standards that are technical, functional, or performance-based.
For example,
- a technical standard could specify that
- the structure of a message containing a patient's blood test results
- must include a header,
- the type of test performed, and
- the results, and further,
- that message must always be put in that sequence
- and be 128 bits long;
- a technical standard could specify that
- a functional standard could specify certain actions that must be consistently accomplished by HIT such as recording the date and time when an electronic prescription is transmitted;
- and a performance standard could specify certain operational requirements for HIT such as being able to properly identify a drug-Allergy contraindication 99.99% of the time for patient safety purposes.
With this in mind, we have chosen to define standard to mean:
- a technical, functional, or performance-based rule, condition, requirement, or specification that stipulates instructions, fields, codes, data, materials, characteristics, or actions.
