Regulatory Requirements
DHIN Regulations
In order to fulfill the requirements of its enabling legislation (Title 16, Chapter 103 of the Delaware Code), DHIN has published regulations on a number of topics. These regulations set forth, among other things, requirements associated with submitting data to and accessing data from DHIN:
- DHIN Regulations on Participation and Use of Data
- DHIN Regulations on Use of Clinical Data for Approved Analytic Purposes
Delaware Health Care Claims Database Regulations
In addition to the services it performs with respect to clinical data, DHIN also hosts the Delaware Health Care Claims Database (HCCD). In enabling the HCCD, the State of Delaware required certain insurance companies providing services in Delaware and to Delaware residents to submit claims information to DHIN’s HCCD to be used to improve the quality and decrease the cost of care in the State of Delaware. In addition to the enabling legislation (Title 16, Chapter 103, Subchapter II of the Delaware Code), the submission of data to DHIN for use in the HCCD and the use of data from the HCCD is governed by regulations:
- Delaware Health Care Claims Database Data Collection Regulation
- Delaware Health Care Claims Database Data Access Regulation
State of Maryland – Reproductive Health Services – Protected Information (effective 12/1/23)
In its most recent legislative session, the State of Maryland enacted a law restricting health information exchanges (HIEs) operating within Maryland from providing access to data associated with abortion and abortion-related care to their participants without explicit patient consent. The specific procedure, drug and associated codes that will be blocked from distribution are currently not defined, but are expected to be published in emergency regulations during the month of December.
As an HIE registered to do business in Maryland, Delaware Health Information Network (DHIN) is required to comply with these regulations and is in the process of deploying the code needed to ensure that Maryland restrictions on data distribution are followed.
Clinical data associated with the following reproductive health services provided at a location in the state of Maryland will be blocked from view in the Community Health Record and not delivered through DHIN’s Results Delivery, ENS or Clinical Gateway services:
- Mifepristone data, or the diagnosis, procedure, medication and related codes for abortion care and other sensitive reproductive health procedures identified by the State of Maryland’s Department of Health.
The most recent draft of the applicable codes that was provided to DHIN is available here. As advised by the Maryland Health Care Commission, DHIN expects the Maryland Department of Health to publish emergency regulations in December that may amend the applicable codes. DHIN will continue to monitor the regulations published by the State of Maryland and work promptly to implement the requirements.
DHIN has begun implementing these protections on new data received by DHIN and expects to complete the restrictions on distribution in the coming weeks. DHIN is also working on the expected requirement to block historical data provided to DHIN after May 31, 2022 and expects to have that data suppressed in the Community Health Record in early 2024.
DHIN is working with our partners to modify our consent tool to apply to this specific type of data and permit patients to choose to share this important reproductive health information with the providers and others involved in their care. Further details will be provided early in 2024.
For information about the restrictions on access and DHIN’s registration, please contact the Maryland Health Care Commission. DHIN expects the emergency regulations from the State of Maryland to be published this month and encourages any interested parties to take advantage of their right to review and comment on those regulations.
Additional information about these regulations will be available here within a reasonable time period after the regulations are published. If you have any questions about DHIN’s compliance, please reach out to DHIN’s Service Desk and you will be connected to the appropriate personnel at DHIN.
Prior Authorization Reporting
In an effort to improve transparency in the pre-authorization approval and decline rates by health plans, Delaware law (Title 18, Subchapter V of the Delaware Code) now requires the submission of prior authorization data to Delaware Health Information Network (DHIN) at least twice a year.
Health insurers, health benefit plans and health service corporations are required to report to DHIN de-identified statistics regarding pre-authorization approvals, denials and appeals in the specified format [linked below] by January 31st and July 31st of each calendar year.
Q&A from conference call with DHIN and the Department of Insurance (1/31/18)
Pre-authorization reporting requirements and reporting spreadsheet