confidentiality a board perspective michael a monÉ jd ky board of pharmacy

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CONFIDENTIALITY A BOARD PERSPECTIVE MICHAEL A MONÉ JD KY BOARD OF PHARMACY

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Page 1: CONFIDENTIALITY A BOARD PERSPECTIVE MICHAEL A MONÉ JD KY BOARD OF PHARMACY

CONFIDENTIALITY

A BOARD PERSPECTIVE

MICHAEL A MONÉ JD

KY BOARD OF PHARMACY

Page 2: CONFIDENTIALITY A BOARD PERSPECTIVE MICHAEL A MONÉ JD KY BOARD OF PHARMACY

Disclaimer

• This is not legal advice.

• Opinions expressed here are my own.

• Opinions are not binding on any employer, past, present or future.

• Opinions are not binding on me as I reserve the right to change my mind.

Page 3: CONFIDENTIALITY A BOARD PERSPECTIVE MICHAEL A MONÉ JD KY BOARD OF PHARMACY

Purpose

• The Board of ________ serves the State or Commonwealth to promote, preserve, and protect the public health, safety, and welfare through effective regulation of the practice of __________.

Page 4: CONFIDENTIALITY A BOARD PERSPECTIVE MICHAEL A MONÉ JD KY BOARD OF PHARMACY

Confidentiality

• Privacy v confidentiality.– one implies that the person has a right not to

disclose.– the other instructs that those with information

are not to disclose what is known or under what circumstances disclosure may occur or when information must be disclosed.

– basically do what your Mom told you to do:• Don’t tell secrets.

Page 5: CONFIDENTIALITY A BOARD PERSPECTIVE MICHAEL A MONÉ JD KY BOARD OF PHARMACY

Public / Professional Duties• Distinction between public duty and

professional duty.

• How does the Board accomplish its mission?

• What is the role of professional associations?

Page 6: CONFIDENTIALITY A BOARD PERSPECTIVE MICHAEL A MONÉ JD KY BOARD OF PHARMACY

Right of Public Access

• “free and open examination of public records is in the public interest…” KRS 61.871

• “statute exhibits a general bias favoring disclosure.” 826 SW2d 324,328

• statute facilitates inspection

• statute generally defines time frames

Page 7: CONFIDENTIALITY A BOARD PERSPECTIVE MICHAEL A MONÉ JD KY BOARD OF PHARMACY

Public Records

• “all books, papers, maps, photographs, cards, tapes, disks, diskettes, recordings, software..possession of agency”

• “only to records which are in existence… does not impose an obligation on agencies to create…”

Page 8: CONFIDENTIALITY A BOARD PERSPECTIVE MICHAEL A MONÉ JD KY BOARD OF PHARMACY

Public Records

• US Supreme Court in Forsham and Kissinger “an agency must first either create or obtain a record as a prerequisite to it becoming an ‘agency record’ within the meaning of the (FOIA)”

Page 9: CONFIDENTIALITY A BOARD PERSPECTIVE MICHAEL A MONÉ JD KY BOARD OF PHARMACY

Agency Forms

• What data is collected?

• What data is actually needed?

• Where do you store the data?

• How do you retrieve the data?

• Is the form a requirement of a contractor?

• Does an exemption exist?

Page 10: CONFIDENTIALITY A BOARD PERSPECTIVE MICHAEL A MONÉ JD KY BOARD OF PHARMACY

Exemptions

• “personal nature…invasion of personal privacy.”

• “prospective location of a business or industry…”

• “test questions, scoring keys, and other examination data before it is to be given or...

Page 11: CONFIDENTIALITY A BOARD PERSPECTIVE MICHAEL A MONÉ JD KY BOARD OF PHARMACY

Exemptions

• …if it is to be given again.”

• “agencies involved in administrative adjudication, or in the process of investigation…

• …record open after enforcement action is completed or a decision is made to take no action.”

Page 12: CONFIDENTIALITY A BOARD PERSPECTIVE MICHAEL A MONÉ JD KY BOARD OF PHARMACY

Inspection

• on-site

• copies

• agency response within 3 days

• state specific exception if agency denies all or any part of request

• Circuit Court for review

Page 13: CONFIDENTIALITY A BOARD PERSPECTIVE MICHAEL A MONÉ JD KY BOARD OF PHARMACY

Costs and Fees

• disruption of the operation of the office may constitute a basis for denial. clear and convincing evidence standard

• charges per page and search time

• written request and advance payment

Page 14: CONFIDENTIALITY A BOARD PERSPECTIVE MICHAEL A MONÉ JD KY BOARD OF PHARMACY

General Requirements

• Suitable facilities

• Time for inspection

• Official custodian

• Rules and Regulations– principal office and office hours

– title and address of custodian

– fees

– procedure to follow to request records

Page 15: CONFIDENTIALITY A BOARD PERSPECTIVE MICHAEL A MONÉ JD KY BOARD OF PHARMACY

Use of the Records

• Commercial purpose– may include staff time

• Non-commercial purpose– no consideration for staff time

Page 16: CONFIDENTIALITY A BOARD PERSPECTIVE MICHAEL A MONÉ JD KY BOARD OF PHARMACY

Privacy

• balancing of the interests

• look to expectation of individual

• reasonableness• “the question of whether an invasion of privacy is

“clearly unwarranted” is intrinsically situational, and can only be determined within a specific context.” 826 SW 2d 324, at 327, 328

Page 17: CONFIDENTIALITY A BOARD PERSPECTIVE MICHAEL A MONÉ JD KY BOARD OF PHARMACY

Privacy

• Social Security Number

• Date of Birth

• Mother’s Maiden Name

• Place of Birth

• Home address

• Home phone number

• Marital Status

Page 18: CONFIDENTIALITY A BOARD PERSPECTIVE MICHAEL A MONÉ JD KY BOARD OF PHARMACY

Licensure

• Application form

• Examination preparation– potential conflict with open meetings laws

• Examination grading

• Examination contractor– breath of exemptions

Page 19: CONFIDENTIALITY A BOARD PERSPECTIVE MICHAEL A MONÉ JD KY BOARD OF PHARMACY

Discipline

• Complaint

• Investigative Report

• Probable Cause Hearing

• Board Hearing

• Formal Hearing

• Final Order

Page 20: CONFIDENTIALITY A BOARD PERSPECTIVE MICHAEL A MONÉ JD KY BOARD OF PHARMACY

Post Discipline Issues

• Board Newsletters– What information is published?

• Board Web Sites– How is the information organized?

• HIPDB– Is this an adequate method for the public to be

informed?

Page 21: CONFIDENTIALITY A BOARD PERSPECTIVE MICHAEL A MONÉ JD KY BOARD OF PHARMACY

Ex parte Communications

• Tendency upon the part of professionals to look at the Board as a vehicle to protect them.

• Purpose is to protect the public from the professionals.

• If the issue is to be decided, discipline or substantive, must be done on the record.

Page 22: CONFIDENTIALITY A BOARD PERSPECTIVE MICHAEL A MONÉ JD KY BOARD OF PHARMACY

HIPAA

• Health Insurance Portability and Accountability Act– Passed by Congress in 1996– Four Areas

• EDI Transactions ad Code Sets

• National Health Identifiers

• Security Requirements (data integrity)

• Privacy Rules…….April 14, 2003

Page 23: CONFIDENTIALITY A BOARD PERSPECTIVE MICHAEL A MONÉ JD KY BOARD OF PHARMACY

HIPAA• Main Provision

– “ A covered entity may not use or disclose protected health information , except as otherwise permitted or required”

• Covered Entity– Health Care Plans

– Health Care Providers (who transmit health information in electronic form)

Page 24: CONFIDENTIALITY A BOARD PERSPECTIVE MICHAEL A MONÉ JD KY BOARD OF PHARMACY

HIPAA

• What’s Covered?– Individually identifiable health information

• Demographic Information

• Created or received from a health care provider

• Collected from an individual

Page 25: CONFIDENTIALITY A BOARD PERSPECTIVE MICHAEL A MONÉ JD KY BOARD OF PHARMACY

HIPAA

• The issue of identity and de-identification– Name

– Address

– Relatives

– DOB

– Tele #

– SSN

– Medical Record #

– Etc

Page 26: CONFIDENTIALITY A BOARD PERSPECTIVE MICHAEL A MONÉ JD KY BOARD OF PHARMACY

HIPAA

• Consent– Rules

• Notices– Posting– Rights – Complaints

Page 27: CONFIDENTIALITY A BOARD PERSPECTIVE MICHAEL A MONÉ JD KY BOARD OF PHARMACY

HIPAA

• New administration rules– Comment period– Dramatic changes– Claims:

• Strengthen notice provisions and remove consent requirements hindering access to care.

• Provides for inter-professional communications, retains minimum necessary.

Page 28: CONFIDENTIALITY A BOARD PERSPECTIVE MICHAEL A MONÉ JD KY BOARD OF PHARMACY

HIPAA

– Claims:• Assures parental access to children’s records. State

laws govern parental access to records.

• Prohibits use of records for marketing – must have authorization before marketing.

• Administrative simplification by reduction to one authorization for permission for a specific use or disclosure that otherwise would not be permitted.

Page 29: CONFIDENTIALITY A BOARD PERSPECTIVE MICHAEL A MONÉ JD KY BOARD OF PHARMACY

HIPAA

• HHS Website– http://aspe.hhs.gov/admnsimp/– http://hhs.gov/ocr/hipaa/finalreg.html

• HIPAA News– http://www.hipaadvisory.com/news

Page 30: CONFIDENTIALITY A BOARD PERSPECTIVE MICHAEL A MONÉ JD KY BOARD OF PHARMACY

Questions

• Thank you