Authenticated PDF Version1.1 Statutory Authority. 16 Del.C. §10306 authorizes the Delaware Health Information Network (DHIN) to promulgate rules and regulations to carry out its objectives under 16 Del.C. Ch. 103, Subchapter II.
"Approved User" means any person or organization that DHIN has authorized to view or access data from the Health Care Claims Database, including Delaware state agencies and DHIN itself.
"Claims Data" means Required Claims Data and any additional health care information that a voluntary reporting entity elects, through entry into an appropriate Data Submission and Use Agreement, to submit to the Delaware Health Care Claims Database.
"Clinical proxy data elements" means any health care information contained within Claims Data which describes a rendered clinical service, including but not limited to: procedure codes, diagnosis codes, dates and locations of clinical services, healthcare providers, and pharmacy data, and excludes Pricing Information.
"Collaborating State Agencies" means the Delaware Office of Management and Budget, State Employee Benefits Committee, Division of Public Health, Division of Medicaid and Medical Assistance, and their successors, if applicable any other agencies identified in 16 Del.C. §10314(c).
“Community Health Record” or “CHR” means a searchable online portal that presents authorized users with a view of a patient’s aggregated clinical data from all sources that contribute health data to DHIN. Access to patient records in the Community Health Record is on the basis of an established relationship between the patient and the end user for purposes of treatment, payment, operations and public health purposes, as those terms are defined in the HIPAA regulations, by patient consent or patient request, or otherwise as set forth in DHIN’s enabling legislation and associated regulations. Patients can opt out of allowing their CHR data to be searchable by anyone who was not the ordering provider, but may not opt out of reporting required by law or regulation, such as, but not limited to, reporting of certain conditions to the Division of Public Health.
"Data Submission and Use Agreement" or "DSUA" means the agreement between the HCCD Administrator and the Reporting Entity describing the specific terms and conditions for data submission and use.
“Data Submission Guide” means the document providing the specific content, formats, timelines, data quality standards and other requirements for claims data submission, incorporated as Addendum One to the DSUA. It shall be established and maintained as a technical guidance document and substantively updated on an annual basis.
"De-identified data" means health information as defined in the HIPAA Privacy Rule, which is not considered PHI because it excludes the following direct and indirect patient identifiers:
|
•
|
|
•
|
|
•
|
Any other unique identifying characteristic or code.
|
|
•
|
"HCCD Administrator" means the Delaware Health Information Network and its staff and any contractors that are responsible for collecting data submissions, providing secure production services and providing data access for approved users.
"Health Care Claims Database" or "HCCD" means the database and associated technology components maintained by DHIN and authorized under 16 Del.C. Ch. 103, Subchapter II.
"Health Care Claims Database Committee" (the "Committee") means the subcommittee established by the Delaware Health Information Network Board of Directors and governed by its by-laws that has the authority to determine when applications for Claims Data should be provided to a data requestor to facilitate the purposes of the enabling legislation, and such other duties as designated by the DHIN Board of Directors consistent with the enabling legislation.
"Health care services" means as defined in 18 Del.C. §6403.
“Health Insurer” means as defined in 16 Del.C. §10312.
"Identified data" means data that contains direct patient identifiers.
"Limited data set" means PHI that excludes 16 categories of direct identifiers and may be used or disclosed, for purposes of research, public health, or health care operations, without obtaining either an individual's authorization or a waiver or an alteration of authorization for its use and disclosure, with a data use agreement. The following data elements are removed from a limited data set:
|
•
|
A limited data set may include:
"Mandatory Reporting Entity" means the following entities, except as prohibited under federal law:
|
•
|
The State Employee Benefits Committee and the Office of Management and Budget, under each entity's respective statutory authority to administer the State Group Health Insurance Program in 19 Del.C. Ch. 96, and any Health Insurer, Third Party Administrator, or other entity that receives or collects charges, contributions, or premiums for, or adjusts or settles health claims for, any State employee, or their spouses or dependents, participating in the State Group Health Insurance Program, except for any carrier, as defined in 29 Del.C. §5290, selected by the State Group Health Insurance Plan to offer supplemental insurance program coverage under 29 Del.C. Ch. 52C.
|
"Member" means individuals, employees, and dependents for which the Reporting Entity has an obligation to adjudicate, pay or disburse claims payments. The term includes covered lives. For employer-sponsored coverage, Members include certificate holders and their dependents. This definition includes all members of the State Group Health Insurance Program regardless of state of residence.
"Pricing Information" means any information referring to prices charged or paid, and includes the pre-adjudicated price charged by a Provider to a Reporting Entity for Health Care Services, the amount paid by a Member or insured party, including co-pays and deductibles, and the post-adjudicated price paid by a Reporting Entity to a Provider for Health Care Services.
"Protected health information" or "PHI" means individually identifiable health information as defined in the HIPAA Privacy Rule.
"Provider" means a hospital, facility, or any health care practitioner licensed, certified, or authorized under State law to provide Health Care Services and includes hospitals and health care practitioners participating in group arrangements, including accountable care organizations, in which the hospital or health care practitioners agree to assume responsibility for the quality and cost of health care for a designated group of beneficiaries.
"Re-disclosure" means the publication, distribution or other dissemination of Claims Data released to an Approved User using any medium and in any format, context or structure.
"Reporting Entity" means either a Mandatory Reporting Entity or a Voluntary Reporting Entity.
"Required Claims Data" as authorized under 16 Del.C. §10312(8) means the required data containing records of member eligibility, medical services claims and pharmacy claims as specified in the Data Submission Guide.
"Voluntary Reporting Entity" means any of the following entities that has chosen to submit or has been instructed to submit data at the request of an employer or client and enters into a Data Submission and Use Agreement, unless such entity is a Mandatory Reporting Entity:
3.0 General Data Access Provisions
3.1 HCCD data may be released to a person or organization for purposes of:
3.1.1 Promoting and improving public health;
3.1.3 Providing information to effectively manage risk for the health needs of a population.
3.3 Except as otherwise specified in this Regulation, all requests for HCCD data or data access shall require completion of a written data request application that describes the intended purpose and use or uses of the data, the justification for the data request, and the security and privacy measures that will be used to safeguard the data and prevent unauthorized access to or use of the data as well as such other acknowledgments as may be included on the application. Exceptions to this rule include:
3.3.2 DHIN may make HCCD clinical proxy data elements available to the Members to whom they apply without a written application or Committee review. Members may access their health data by enrolling in DHIN’s Personal Health Record on the DHIN website at www.DHIN.org.
3.4.1 Requests from Reporting Entities for their own data will not require Committee review.
3.4.4 Applications for de-identified data may be eligible for expedited review.
3.5 DHIN will post an annual summary of disclosures on its website.
4.0 Structure and Duties of the Committee
4.1 The Committee shall have a chairperson and members appointed by the DHIN Board of Directors.
4.4.1 The intended use is consistent with the statutory purpose of the HCCD;
4.4.5 The applicant is qualified to serve as a responsible steward of the requested data.
4.6 After a decision is reached by the Committee, public notice will be posted on the DHIN website that an application for data access was received, by whom it was submitted and for what purposes, and the decision of the Committee to grant or deny the application. The final determination of the Committee shall not be subject to appeal.
5.0 Applications for HCCD Data
5.2.1 Confirmation of compliance with the DHIN's confidentiality and data security protocols;
5.2.2 Confirmation of compliance with the HCCD re-disclosure requirements;
5.2.3 Commitment to use HCCD data for the sole purpose of executing the approved research project;
5.2.4 Commitment to document data destruction processes at the end of the project.
5.2.5 Confirmation of compliance with all statutory and regulatory requirements.
6.0 Re-Disclosure Requirements
7.3.3 Entities that submit other data to the DHIN.
7.5 Fees shall be deposited into a DHIN account to support costs of operating the HCCD.
8.1.1 Revoke permission to use the data;
8.1.2 Pursue civil or administrative enforcement action under applicable Delaware state law.
8.1.3 Notify the requester’s licensing body, if any, and if none, its accreditation body.
