DAR File No. 38081

Health, Disease Control and Prevention, Health Promotion

Rule R384-203

Prescription Drug Database Access

Notice of Proposed Rule

(New Rule)

DAR File No.: 38081
Filed: 10/30/2013 03:56:10 PM

RULE ANALYSIS

Purpose of the rule or reason for the change:

This proposed rule provides procedures for the Utah Department of Health (UDOH) Executive Director to allow access to the controlled substance database to designated individuals conducting scientific studies regarding the use or abuse of controlled substances.

Summary of the rule or change:

This rule establishes procedure and application process for UDOH Executive Director to designate and assign a person who is not an employee of the Department of Health to conduct scientific studies regarding the use or abuse of controlled substances pursuant to Subsection 58-37f-301(2)(d).

State statutory or constitutional authorization for this rule:

• Subsection 58-37f-301(2)(d)

Anticipated cost or savings to:

the state budget:

Cost will be minimal--Likely limited to small amount of staff time required to access data.

local governments:

No Cost--Political subdivisions cannot apply.

small businesses:

No Cost--Small business cannot apply.

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

Only research facilities associated with an accredited university or college in the state can apply for access. Anticipated costs would include the time to complete the application process and obtain Internal Review Board approval.

Compliance costs for affected persons:

Research facilities associated with an accredited university or college may apply and will be required to prepare an application detailing explicit information regarding the purpose of the scientific studies and the scientific studies to be conducted if: 1) the study fits within the responsibilities of the UDOH for health and welfare; and 2) the study has been reviewed and approved by an Institutional Review Board (IRB). Assurances must be provided: 1) that the studies are not conducted for profit or commercial gain; and 2) the designee protects the information on behalf of the Department of Health as a business associate or its equivalent. It is anticipated that it would take approximately five - six hours staff time to prepare their application and obtain IRB approval. Unable to determine cost because of not knowing the salary of staff that will be preparing the application.

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

This should have no impact on business.

David Patton, PhD, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Division 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:

• Heather Borski at the above address, by phone at 801-538-9998, by FAX at 801-538-9495, or by Internet E-mail at hborski@utah.gov

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:

12/16/2013

This rule may become effective on:

12/23/2013

Authorized by:

David Patton, Executive Director

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) 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.

(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 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 obtain, de-identify and provide the data set requested in the application.

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

 

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: 2013

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