(c) Makes a request for the dispensing data monitored prescription drug history report through its PDMP system account with the board.
(9)The board may disclose de-identified PDMP data without personally identifiable information which does not and cannot that could be reasonably used to identify any patient upon written request patient, healthcare professional, practitioner delegate, pharmacist delegate, or dispenser for public health and research purposes..
(10)The board shall disclose the minimum necessary amount of PDMP information in a monitored prescription drug history report about a patient, patient address, practitioner, or dispenser to designated staff of a law enforcement authority in the same or similar manner, and for the same or similar purposes, as those persons are authorized to access similar confidential patient health care records under ss. 146.82 and 961.385, Stats., this chapter, and other state or federal laws and regulations relating to the privacy of patient health care records agency or prosecutorial unit if the designated staff does all of the following:
  (a) Creates an account with the board on a form provided by the board PDMP system.
  (b) Provides a lawful order of a court of record under s. 146.82 (2) (a) 4., Stats., or provides evidence satisfactory to the board that documentation demonstrating the law enforcement agency or prosecutorial unit is entitled to the information under s. 146.82 (2) (a) 11., Stats engaged in one of the following activities:
    1. An active and specific investigation or prosecution of a violation of any state or federal law involving a monitored prescription drug and that the PDMP data information being requested is reasonably related to that investigation or prosecution.
    2. The monitoring of a patient as part of a drug court, as defined in s. 165.955 (1).
  (c) Makes a request for PDMP information the monitored prescription drug history report through its account with the board PDMP system.
Section 36. CSB 4.11 (10) (c) (note) is repealed.
Section 37. CSB 4.12 (title) and (1) are amended to read:
CSB 4.12Use of PDMP information data by the board and department.
(1)The board shall develop and maintain a PDMP database to store dispensing data and PDMP information data in a secure environment and an encrypted format.
Section 38. CSB 4.12 (2) is repealed.
Section 39. CSB 4.12 (2m) is created to read:
CSB 4.12 (2m) The board shall develop and maintain a PDMP system to facilitate all of the following:
  (a) The submission of dispensing data to the PDMP database.
  (b) The creation of monitored prescription drug history reports about specific patients, practitioners, and dispensers.
  (c) The access to and the obtaining of monitored prescription drug history reports, prescribing metrics reports and audit trails.
Section 40. CSB 4.12 (3) is repealed and recreated to read:
CSB 4.12 (3) The board shall maintain audit trails that contain all of the following information:
  (a) A log of dispensing data submitted to the PDMP database by each dispenser.
  (b) A log of persons to whom the Board has granted direct access to the PDMP system under s. CSB 4.093 (4) (a) and a log of each time a person attempts to access PDMP data or a monitored prescription drug history report.
  (c) A log of prescription monitoring programs operated by a relevant agency in another jurisdiction with which the board exchanges PDMP data pursuant to s. CSB 4.14 and a log of each time a person from another jurisdiction attempts to access PDMP data.
  (d) A log of pharmacies or other entities at which pharmacists dispense or administer monitored prescription drugs in the course of professional practice with which the board has determined to have at least equivalent capability to maintain the confidentiality of monitored prescription drug history reports and a log of each time a person from a pharmacy or other entity attempts to access PDMP data or a monitored prescription drug history report.
  (e) A log of hospitals or other entities at which practitioners prescribe, dispense, or administer monitored prescription drugs in the course of professional practice with which the board has determined to have at least equivalent capability to maintain the confidentiality of monitored prescription drug history reports and a log of each time a person from a hospital or other entity attempts to access PDMP data or a monitored prescription drug history report.
  (f) A log of monitored prescription drug history reports and PDMP data disclosed pursuant to s. CSB 4.11, including the name of the person to whom the information was disclosed.
  (g) A log of requests for PDMP data or monitored prescription drug history reports even when no information was disclosed.
Section 41. CSB 4.12 (4), (4g), (4r), and (5) are repealed.
Section 42. CSB 4.12 (6) (intro) and (a) are amended to read:
CSB 4.12(6)Board and department staff Staff assigned administrative duties over the PDMP, vendors, contractors, and other agents of the board shall only have access to the minimum amount of PDMP information data necessary for all of the following purposes:
  (a) The design, implementation, operation, and maintenance of the program, including the PDMP database, PDMP system, the disclosure of information via other entities pursuant to s. CSB 4.09 (4), and the exchange of information pursuant to s. CSB 4.15 as part of the assigned duties and responsibilities of their employment.
Section 43. CSB 4.12 (6) (am) is created to read:
CSB 4.12 (6)(am) The operation of an analytics platform that provides data cleansing and standardization, data integration, advanced analytics, and alert management capabilities as part of the PDMP database and PDMP system.
Section 44. CSB 4.12 (6) (c) is amended to read:
CSB 4.12 (6) (c) Evaluating and responding to legitimate requests for PDMP information monitored prescription drug history reports, audit trails, and PDMP data.
Section 45. CSB 4.12 (6) (cg) and (cr) are created to read:
CSB 4.12 (6) (cg) Preparing monitored prescription drug history reports, audit trails, and PDMP data for the board to determine whether suspicious or critically dangerous conduct or practices has occurred or is occurring pursuant to s. CSB 4.15.
  (cr) Conducting a review of the program as required by s. 961.385 (5), Stats.
Section 46. CSB 4.13 is amended to read:
CSB 4.13Confidentiality of PDMP information records. (1)The dispensing data, PDMP information data, audit trails, monitored prescription drug history reports, and prescribing metrics reports maintained, by the board, department or a vendor contracting with the department which is submitted to, maintained created, or stored as a part of the program is are not subject to inspection or copying under s. 19.35, Stats.
(2)A person who discloses or a person whose delegate discloses dispensing data, PDMP information data, audit trails, monitored prescription drug history reports, or prescribing metrics reports in violation of s. 146.82 or 961.385, Stats., this chapter, or other state or federal laws or regulations relating to the privacy of patient health care records, may be subject to disciplinary action by referred to the appropriate licensing or regulatory board that issued the license under which the person is authorized to prescribe or dispense monitored prescription drugs and all appropriate civil and criminal penalties for discipline, or the appropriate law enforcement agency for investigation and possible prosecution.
Section 47. CSB 4.14 (title) and (1) (intro) are amended to read:
CSB 4.14Exchange of PDMP information data. (1)The board may exchange monitored prescription drug history reports and PDMP information data with a prescription monitoring program operated by a relevant agency in another state or jurisdiction if the prescription monitoring program satisfies all of the following conditions:
Section 48. CSB 4.15 (1) and (5) (intro) are amended to read:
CSB 4.15 (1)The board may review dispensing data, monitored prescription drug history reports, PDMP information data, and data compiled pursuant to s. CSB 4.12 to determine whether circumstances indicate suspicious or critically dangerous conduct or practices of a pharmacist, pharmacy, practitioner, or patient.
(5)Upon determining that circumstances indicate suspicious or critically dangerous conduct or practices of a pharmacy, practitioner, or patient, the Board may disclose PDMP information monitored prescription drug history reports, audit trails, and PDMP data to any of the following:
Section 49. EFFECTIVE DATE. The rules adopted in this order shall take effect on April 1, 2017 and remain in effect until January 1, 2018, or the date on which permanent rules take effect, whichever is sooner.
(END OF TEXT OF RULE)
Dated __March 23, 2017__     Agency               Douglas Englebert,Chair
            Controlled Substances Board
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