Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 25 - MARYLAND HEALTH CARE COMMISSION › Chapter 10.25.05 - Small Group Market Data Collection › Section 10.25.05.02 - Definitions

Current through Register Vol. 51, No. 14, July 12, 2024
A. In this chapter,
				  the following terms have the meanings indicated.
B. Terms Defined.
(1) "All-payor claims database" or "APCD"
				  means a large-scale database that systematically collects and aggregates
				  enrollment, claims, and provider information from private and public payors in
				  a state.
(2) "Applicant" means a
				  person, governmental entity, or other entity that submits an application
				  requesting data from the Commission.
(3) "Application" means a written request for
				  data submitted in the form and manner specified by the Commission.
(4) "Commission" means the Maryland Health
				  Care Commission.
(5) "Data extract"
				  means a subset of information from the Maryland medical care database or other
				  data base maintained by the Commission based on criteria provided by an
				  applicant.
(6) "Data recipient"
				  means a person, governmental entity, or other entity whose application has been
				  approved and who is authorized to access and use data requested in an
				  application in accordance with a data use agreement.
(7) "Data release" means the process of
				  providing a data recipient with access and use of data requested in an
				  application in accordance with a data use agreement.
(8) "Data Release Advisory Committee" or
				  "DRAC" means a multi-stakeholder group of individuals appointed by the
				  Commission whose functions include but are not limited to that of privacy board
				  review as described in 45
				  CFR §
												164.512, reviewing completed
				  applications, and making a written recommendation to the Executive Director
				  regarding whether an application should be approved, approved with conditions,
				  or disapproved.
(9) "Data set"
				  means a collection of separate data elements or variables that can be
				  manipulated as a unit.
(10) "Data
				  use agreement" means a written contractual document entered into between the
				  Commission and a data recipient that contains terms and conditions that govern
				  a data recipient's access to and use of data provided by the
				  Commission.
(11) "De-identified
				  data" means information that does not identify an individual and for which
				  there is no reasonable basis to believe that it can be used to identify an
				  individual.
(12) "Direct individual
				  identifier" means personal information such as name, Social Security number,
				  and date of birth that uniquely identifies an individual or that can be
				  combined with other readily available information to uniquely identify an
				  individual.
(13) "Disclose" means
				  the release, redisclosure, transfer, provision, access, transmission,
				  communication, or divulgence in any other manner of data release pursuant to
				  this chapter.
(14) Entity.
(a) "Entity" means a person, partnership,
				  firm, association, limited liability company, limited liability partnership, or
				  public or private corporation.
(b)
				  "Entity includes a county or municipality of Maryland or a governmental entity
				  of another state.
(15)
				  "Executive Director" means the Executive Director of the Maryland Health Care
				  Commission.
(16) "Funding source"
				  means any federal or state governmental entity, public or private corporation
				  or organization, educational or research institution or organization,
				  foundation, person, individual, or other entity that has committed to give or
				  grant, or has already given or granted, monetary funds to an applicant to cover
				  all or part of the costs of the proposed use of the data described in an
				  application submitted to the Commission.
(17) Governmental Entity.
(a) "Governmental entity" means any agency,
				  authority, board, commission, council, department, instrumentality, unit, or
				  other body of State government or the federal government that is established by
				  law.
(b) "Governmental entity" does
				  not include a county or municipality of Maryland or a governmental entity of
				  another state.
(18)
				  "HIPAA" means the United States Health Insurance Portability and Accountability
				  Act of 1996, P.L. 10491, as implemented and amended in federal regulations,
				  including the HIPAA Privacy and Security Rules, 45 CFR Parts 160 and 164, as
				  they may be amended, modified, or renumbered, including as amended by the
				  Health Information Technology for Economic and Clinical Health (HITECH)
				  Act.
(19) "Identifiable data" means
				  information that contains data elements that can be used to identify a specific
				  individual.
(20) "Indirect
				  individual identifier" means a data element that can be used to identify an
				  individual when combined with other information or data.
(21) "Institutional Review Board" or "IRB"
				  has the meaning stated in 45 CFR Part 46, and any subsequent revisions of those
				  regulations, as they may be amended, modified, or renumbered, regarding the
				  protection of human subject research.
(22) "Medicaid" means the Maryland Medical
				  Assistance Program.
(23) "Medical
				  Care Data Base" or "MCDB" means the data base established and maintained by the
				  Commission pursuant to Health-General Article, § 19-133, Annotated Code of
				  Maryland, that collects eligibility data, professional services claims,
				  institutional services claims, pharmacy claims, and provider data for Maryland
				  residents enrolled in private insurance, Medicaid, or Medicare. The MCDB is
				  Maryland's all-payer claims data base.
(24) "Person" means an individual, receiver,
				  trustee, guardian, personal representative, fiduciary, representative of any
				  kind, partnership, firm, association, corporation, or other entity.
(25) "Product" means any creation derived in
				  whole or part from data released pursuant to this chapter, including an
				  analysis, article, chart, compilation, display, finding, graph, information,
				  manuscript, map, presentation, publication, report, service, software, study,
				  subscription service, summary, table, or website.
(26) "Protected health information" or "PHI"
				  means individually identifiable health information as defined in the HIPAA
				  Privacy Rule at 45 CFR
				  §
												160.103, as it may be amended,
				  modified, or renumbered.
(27)
				  "State" means:
(a) When capitalized, the
				  State of Maryland; or
(b) When
				  lowercase, any state, possession, territory, or commonwealth of the United
				  States, or the District of Columbia.