R436.

Health, Center for Health Data and Informatics, Vital

Records and Statistics.
R436-55. Hemp Extract Registration.
R436-55-1. Legal Authority.
This rule is promulgated under authority granted in Utah
Code Title 26, Chapter 55.
R436-55-2. Purpose.
This rule establishes the general procedures and
requirements that an individual must follow to obtain and
maintain a hemp extract registration card.
R436-55-3. Definitions.
For purposes of this rule, the definitions in Section
26-55-102 apply, in addition:
(1) "Applicant" means any individual applying for a hemp
extract registration card.
(2) "Evaluation record" means the neurologists clinical
evaluation and observation records as described in Subsection
26-55-103(7).
(3) "Higher education institute" as defined in 20 U.S.C.
Sec. 1001.
(4) "Institutional Review Board" or "IRB" means a multi-
disciplinary committee which reviews proposed research involving
human subjects.
(5) "Qualifying patient" means an individual who has been
diagnosed by a neurologist as having intractable epilepsy.
(6) "Written certification" means a non-prescription
statement signed by a neurologist that indicates the qualifying
patient suffers from intractable epilepsy and may benefit from
the use of hemp extract. The statement may be on a form
prescribed by the department or in another format.
R436-55-4. Application for a Hemp Extract Registration Card.
(1) For an applicant who is a qualifying patient and is at
least 18 years of age, the applicant shall submit the following
to the department:
(a) an application on a form prescribed by the department
that includes:
(i) the applicant's name, date of birth, and address; and
(ii) the name, address, and telephone number of the
neurologist providing the written certification;
(b) a copy of the applicant's photographic identification;
(c) proof of Utah residency;
(d) a written certification; and
(e) the applicable fee.
(2) To apply for a hemp extract registration card for a
qualifying patient who is under 18 years of age, the qualifying
patient's parent shall submit the following to the department:
(a) an application on a form prescribed by the department
that includes:
(i) the qualifying patient's name, date of birth, and
address;
(ii) the parent's name and address;
(iii) the name, address, and telephone number of the
neurologist providing the written certification;
(b) a copy of the parent's photographic identification;
(c) proof of the parents Utah residency;
(d) an attestation that the parent is responsible for
health care decisions for the qualifying patient;
(e) a written certification; and
(f) the applicable fee.
R436-55-5. Submission of an Evaluation Record.
(1) The neurologist shall transmit the evaluation record
to the department by first class mail or through secure
electronic transmission within five business days after signing
a written certification or upon request by the department.
(2) The evaluation record must include at least the
following:
(a) the qualifying patients name and date of birth;
(b) date of clinic office visit;
(c) the neurologist's name, Department of Professional
Licensing number and expiration date;
(d) diagnosis of epilepsy; and
(e) if evaluation record is submitted for the initial
registration, an indication that qualifying patient currently
suffers from intractable epilepsy; or
(f) if evaluation record is submitted after registration
of a hemp extract registration card:
(i) the hemp extracts effect on seizure control; and
(ii) any adverse effects or other effects that may be
attributed to use of the hemp extract.
(3) In addition to the requirements listed in subsection
(2), the department recommends the evaluation record include,
which may be based on self-reporting to the neurologist by the
qualified patient, the following:
(a) hemp extract information, such as the supplier,
product description, dosage, frequency of use, and duration of
use by the qualifying patient;
(b) frequency of seizures before and after use of hemp
extract;
(c) evidence supporting the diagnosis of intractable
epilepsy; and
(d) information about other treatments or medications,
including dosage, frequency and dates of use, used to treat or
control qualifying patient's epilepsy.
(4) For an evaluation record, a neurologist may either
complete the evaluation record on a form prescribed by the
department or may provide it in another format.
R436-55-6. Issuance, Expiration, and Renewal of Hemp Extraction
Registration Card.
(1) If an application is approved, the department shall
issue a hemp extract registration card to the applicant. The
hemp extract registration card must include the following:
(a) the registrant's name, date of birth, and address;
(b) the qualifying patient's name, date of birth, and
address, if the qualifying patient is under 18 years of age;
(c) an issuance date and expiration date;
(d) the neurologist's name, Department of Professional
Licensing number and expiration date; and
(e) a department-issued registry identification number.
(2) A hemp extract registration card issued to a
registrant is valid for one year after the issuance date unless
revoked or surrendered.
(3) To maintain a valid hemp extract registration card, a
registrant shall submit at least fifteen business days prior to
the expiration date on the hemp extract registration card the
following to the department:
(a) a renewal application on a form prescribed by the
department;
(b) a new written certification; and
(c) the renewal fee.
R436-55-7. Application Denial; Revocation of Hemp Extract
Registration Card.
(1) The Department shall deny an application for a hemp
extract registration card that:
(a) contains false information, including a false name,
address, written certification, date of birth, or photo
identification; or
(b) fails to provide an evaluation record or any of the
information required by Section R436-55-4.
(2) The Department shall return the denied application to
the applicant, accompanied by an explanation of the reason for
its return.
(3) The Department shall revoke a hemp extract
registration card upon finding that a registrant or neurologist
submitted false information to the department.
R436-55-8. Interim Changes.
(1) When there has been a change in the qualifying
patients name, address, or neurologist, the registrant must
notify the department within ten business days by submitting a
form as prescribed by the department.
(2) A registrant shall report to the department upon
discovery that the registrant's hemp extract registration card
is lost, stolen, or damaged. The registrant may request a
replacement card.
(3) If the department issues a new hemp extract
registration card to a registrant based on a request for a
replacement card or an application to update information on the
hemp extract registration card, the replacement card shall have
the same expiration date as the hemp extract registration card
being replaced or updated.
R436-55-9. Verification of Registry to Law Enforcement.
The department may verify to a law enforcement agency
whether an individual is a lawful possessor of a hemp extract
registration card, without disclosing more information than is
reasonably necessary to verify the authenticity of the hemp
extract registration card.
R436-55-10. Review and Approval of Research Requests.
(1) If the researcher requests statistical information,
the department shall provide the higher education institution
with the requested statistical information upon receipt of the
written request and payment of the associated costs.
(2) If the research involves the use of identifiable
health data, the request must be in writing and must be signed
by the researcher of the higher education institution. In
addition:
(a) The request must outline the research protocol to be
used. Approval by an Institutional Review Board must be included
with the request.
(b) If the research involves a follow-back or follow-up
study, the request must describe who is to be contacted, how, by
whom, and what questions will be asked. If a survey is planned,
a copy of the survey must be submitted.
(c) If the research involves linking data files, the
variables to be used to determine the match must be identified.
(d) The researcher and all persons who may have access to
the identifying health data in the evaluation records shall sign
a confidentiality agreement, which is available from the
department.
(e) The researcher may not use or allow other persons to
use the evaluation records for any purpose other than the
approved research.
(f) The department shall review each research request and
notify the requestor one of the following:
(i) The request is approved and the researcher is notified
in writing of the approval and of the associated costs.
(ii) The request is given tentative approval and the
researcher:
(A) is notified in writing of the approval and associated
costs; and
(B) discusses and resolves concerns identified by the
department.
(iii) The request is not approved and the researcher is:
(A) notified in writing the reasons for the disapproval;
(B) notified of the areas of concern with the request;
(C) allowed to address the areas of concern and resubmit
the request; and
(D) notified that the decision to deny may be appealed to
the Executive Director of the Department of Health.
KEY: Hemp Extract Registration.
Authorizing, and Implemented or Interpreted Law: 26-55.