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

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.

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 __________.

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.

Public / Professional Duties• Distinction between public duty and

professional duty.

• How does the Board accomplish its mission?

• What is the role of professional associations?

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

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…”

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)”

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?

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...

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.”

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

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

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

Use of the Records

• Commercial purpose– may include staff time

• Non-commercial purpose– no consideration for staff time

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

Privacy

• Social Security Number

• Date of Birth

• Mother’s Maiden Name

• Place of Birth

• Home address

• Home phone number

• Marital Status

Licensure

• Application form

• Examination preparation– potential conflict with open meetings laws

• Examination grading

• Examination contractor– breath of exemptions

Discipline

• Complaint

• Investigative Report

• Probable Cause Hearing

• Board Hearing

• Formal Hearing

• Final Order

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?

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.

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

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)

HIPAA

• What’s Covered?– Individually identifiable health information

• Demographic Information

• Created or received from a health care provider

• Collected from an individual

HIPAA

• The issue of identity and de-identification– Name

– Address

– Relatives

– DOB

– Tele #

– SSN

– Medical Record #

– Etc

HIPAA

• Consent– Rules

• Notices– Posting– Rights – Complaints

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.

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.

HIPAA

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

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

Questions

• Thank you