No. 43562 (Amendment): Rule R384-203. Prescription Drug Database Access

(Amendment)

DAR File No.: 43562
Filed: 03/04/2019 09:09:02 AM

RULE ANALYSIS

Purpose of the rule or reason for the change:

This rule is required in Subsection 58-37f-301(2)(f) and there have been amendments to this code since the rule was established. In addition, clarifications have been made to the application process.

Summary of the rule or change:

This rule is required in Subsection 58-37f-301(2)(f) and there have been amendments to this code since the rule was established. The code has changed from Subsection 58-37f-301(2)(f) to Subsection 58-37f-301(2)(e), the definition of "research facility" has expanded, and clarifications related to the application process are being made.

Statutory or constitutional authorization for this rule:

• Subsection 58-37f-301(2)(e)

Anticipated cost or savings to:

the state budget:

These rule changes are administrative and do not impact the current state budget.

local governments:

These rule changes are administrative and do not impact local governments.

small businesses:

These rule changes are administrative and do not impact small businesses.

persons other than small businesses, businesses, or local governmental entities:

These rule changes are administrative and do not impact other persons.

Compliance costs for affected persons:

There are no compliance costs associated with these rule changes. These rule changes are administrative.

Comments by the department head on the fiscal impact the rule may have on businesses:

There will be no fiscal impact to businesses because the changes are administrative rather than substantive.

Joseph K. Miner, MD, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Office of Administrative Rules, or at:

Health
Disease Control and Prevention, Health Promotion
CANNON HEALTH BLDG
288 N 1460 W
SALT LAKE CITY, UT 84116-3231

Direct questions regarding this rule to:

• Anna Fondario at the above address, by phone at 801-538-6201, by FAX at , or by Internet E-mail at [e-mail]

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

05/01/2019

This rule may become effective on:

05/08/2019

Authorized by:

Joseph Miner, Executive Director

RULE TEXT

Appendix 1: Regulatory Impact Summary Table*

Fiscal Costs

FY 2019

FY 2020

FY 2021

State Government

$0

$0

$0

Local Government

$0

$0

$0

Small Businesses

$0

$0

$0

Non-Small Businesses

$0

$0

$0

Other Person

$0

$0

$0

Total Fiscal Costs:

$0

$0

$0

Fiscal Benefits

State Government

$0

$0

$0

Local Government

$0

$0

$0

Small Businesses

$0

$0

$0

Non-Small Businesses

$0

$0

$0

Other Persons

$0

$0

$0

Total Fiscal Benefits:

$0

$0

$0

Net Fiscal Benefits:

$0

$0

$0

 

*This table only includes fiscal impacts that could be measured. If there are inestimable fiscal impacts, they will not be included in this table. Inestimable impacts for State Government, Local Government, Small Businesses and Other Persons are described in the narrative. Inestimable impacts for Non - Small Businesses are described in Appendix 2.

 

Appendix 2: Regulatory Impact to Non - Small Businesses

This rule change is not expected to have any fiscal impacts on non-small businesses' revenues or expenditures, because the changes only expand the institutions eligible to request data and makes clarifications to the process between the Utah Department of Health and the Division of Occupational and Professional Licensing.

 

The executive director of the Utah Department of Health, Joseph Miner, MD, has reviewed and approved this fiscal analysis.

 

 

R384. Health, Disease Control and Prevention; Health Promotion.

R384-203. Prescription Drug Database Access.

R384-203-1. Authority and Purpose.

This rule establishes procedures and application processes pursuant to Title 58-37f-301(2)([d]f) for Utah Department of Health Executive Director to allow access to the Prescription Drug database by a designated and assigned person to conduct scientific studies regarding the use or abuse of controlled substances, who is not an employee of the Department of Health.

 

R384-203-2. Definitions.

The following definitions apply to this rule:

(1) "Department" means the Utah Department of Health.

(2) "Director" means the Utah Department of Health Executive Director.

(3) "Prescription Drug Database" means the Utah Controlled Substance Database.

(4) "Research facility" means a research facility associated with a university or college in the state accredited by [the Northwest Commission on Colleges and Universities]one or more regional or national accrediting agencies recognized by the United States Department of Education.

(5) "Institutional Review Board" means a board that is approved for human subject research by the United States Department of Health and Human Services.

(6) "Designee" means a person designated and assigned by the Director to have access to data from the Prescription Drug database in order to conduct scientific studies regarding the use or abuse of controlled substances, who is not an employee of the Department.

(7) "Business associate" means a business associate as defined under the HIPAA privacy, security, and breach notification rules in 45 CFR 164.502(a), 164.504(e), and 164.532(d) and (e).

(8) "De-identified" means information as defined in 45 CFR 164.502(d) and 164.514(a), (b), and (c).

 

R384-203-3. Criteria for Application to Access Prescription Drug Database.

(1) The study must fit within the responsibilities of the Department for health and welfare.

(2) De-identified prescriber, patient and pharmacy data will meet the research needs.

(3) The research facility designee must provide:

(a) written assurances that the studies are not conducted for and will not be used for profit or commercial gain;

(b) written assurances that the designee shall protect the information as a business associate of the Department of Health; and

(c) documentation of an Institutional Review Board approval.

 

R384-203-4. Research Application Process.

(1) The research facility designee will prepare and submit for Department approval an application as designated by the Department detailing explicit information regarding the scientific studies to be conducted including the:

(a) purpose of the study;

(b) research protocol for the project;

(c) description of the data needed from the database to conduct that research;

(d) plan that demonstrates all database information will be maintained securely, with access being strictly restricted to the designee and research study staff; and

(e) provisions for electronic data to be stored on a secure database computer system with access being strictly restricted to the designee and research study staff.

(2) Application will be reviewed by the Department's Institutional Review Board and recommendation made to the director for or against approval.

(3) Director will determine approval status of the application.

[(4) Designee will sign the Department's data sharing agreement if application is approved by the Director.]

 

R384-203-5. Data Provision and Fees.

(1) Department will send signed copy of application and Institutional Review Board approval to the Division of Occupational and Professional Licensing (DOPL).

([1]2) DOPL[Department] will [obtain, ]de-identify and provide the data set requested in the application , unless a written agreement is signed by DOPL requesting the Department to provide the data set.

(2) Research facility and designee shall pay all relevant expenses for data transfer, [and ]manipulation, and analysis.

 

R384-203-6. Audit Provisions.

Research facility and designee shall submit, upon request, to a Department audit of the recipients' compliance with the terms of the data sharing agreement.

 

KEY: prescription drug database, controlled substances, substance abuse database

Date of Enactment or Last Substantive Amendment: [March 1, 2014]2019

Authorizing, and Implemented or Interpreted Law: 58-37f-301(2)([d]f)

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