(a) The Secretary, in consultation with the Board, shall adopt regulations to carry out this subtitle.
(b) The regulations adopted by the Secretary shall:
(1) Specify the prescription monitoring data required to be submitted under § 21–2A–03 of this subtitle;
(2) Specify the electronic or other means by which information is to be submitted:
(i) Without unduly increasing the workload and expense on dispensers; and
(ii) In a manner as compatible as possible with existing data submission practices of dispensers;
(3) Specify that the information be submitted by dispensers once every 24 hours;
(4) Specify that the Program:
(i) Shall provide the information technology software to dispensers necessary to upload prescription drug monitoring data to the Program; and
(ii) May not impose any fees or other assessments on prescribers or dispensers to support the operation of the Program;
(5) Identify the mechanism by which prescription monitoring data are disclosed to a person, in accordance with § 21–2A–06 of this subtitle;
(6) Identify the circumstances under which a person may disclose prescription monitoring data received under the Program;
(7) Specify the process for the Program’s review of prescription monitoring data and reporting of:
(i) Possible misuse or abuse of a monitored prescription drug under § 21–2A–06(c) of this subtitle; or
(ii) A possible violation of law or possible breach of professional standards under § 21–2A–06(d) of this subtitle;
(8) Establish requirements for Program retention of prescription monitoring data for 3 years; and
(9) Require that:
(i) Confidential or privileged patient information be kept confidential; and
(ii) Records or information protected by a privilege between a health care provider and a patient, or otherwise required by law to be held confidential, be filed in a manner that, except as otherwise provided in § 21–2A–06 of this subtitle, does not disclose the identity of the person protected.
Structure Maryland Statutes
Title 21 - Food, Drugs, and Cosmetics
Subtitle 2A - Prescription Drug Monitoring Program
Section 21-2A-01 - Definitions
Section 21-2A-03 - Implementation and Operation; Prescription Monitoring Data
Section 21-2A-04 - Regulations
Section 21-2A-04.1 - Registration of Prescribers With Program
Section 21-2A-04.2 - Prescription Monitoring by Prescribers
Section 21-2A-05 - Advisory Board
Section 21-2A-06 - Prescription Monitoring Data