CHPC Candidate Group

1.  A couple of questions

Posted 5 days ago
Reading through my Healthcare Privacy Compliance Handbook ... Not to be critical, but sometimes the handbook is repetitive and confusing ... Comparing old regulation to new ... Anyone else find this??

Can anyone simplify what is meant by a conditioned authorization and an unconditioned authorization for research example?  I know that the authorizations can now be combined ... But I really do not know what is meant by conditioned and unconditioned.  Any simplification would be appreciated!

My second question in regards to research and authorizations ... When it comes to privacy ... The handbook speaks to future research if a HIPAA covered entity would need to seek authorization for each specific research use and disclosure.  If not a covered entity additional authorization would not be necessary.  What type of organizations are out there conducting research other than a CE .... Would this be like universities?  Foundations?

Thanks for any and all feedback!

Donna

------------------------------
Donna Gosselin CHC
Director of Corporate Compliance and Quality
Maine Veterans' Homes
Augusta,ME
------------------------------


2.  RE: A couple of questions

Posted 5 days ago
Donna,
I have no clarification for your questions but I would like to add a caution. The section on drug and alcohol section is now outdated with the big recent changes to 42 CFR Part 2 Regulations. Hopefully they will release an updated version soon.

------------------------------
Brittanie Terrell
HIPAA Privacy/Security Officer

------------------------------



3.  RE: A couple of questions

Posted 5 days ago
Just to caution further: The final rule to 42 CFR Part 2 was delayed until at least TODAY, so unless SAMHSA has stated it is now in effect, we are still subject to the old version, right?

------------------------------
David Rothery, CHC
Compliance Officer
Marin County, CA


These are my personal opinions and not those of the County of Marin
------------------------------



4.  RE: A couple of questions

Posted 5 days ago
Yikes. David, I did not realize it was postponed. I do not work with a facility directly subject to it. My client is a regular counseling practice. We have been working on what if any changes will apply to them.

------------------------------
Brittanie Terrell
HIPAA Privacy/Security Officer

------------------------------



5.  RE: A couple of questions

Posted 5 days ago
I have checked the SAMHSA and Legal Action Center websites, and do not see anything indicating that the final rule will be effective any time soon.

------------------------------
David Rothery, CHC
Compliance Officer
Marin County, CA


These are my personal opinions and not those of the County of Marin
------------------------------



6.  RE: A couple of questions

Posted 5 days ago
The last I heard was the revised Part 2 regs are still on hold, but that was a few days ago.

------------------------------
David Garrison CHC
Compliance/Privacy Officer
SEARHC
Juneau,AK
------------------------------



7.  RE: A couple of questions

Posted 5 days ago
It appears tomorrow is supposed to be the effective date: Confidentiality of Substance Use Disorder Patient Records; Delay of Effective Date
Federal Register remove preview
Confidentiality of Substance Use Disorder Patient Records; Delay of Effective Date
On January 18, 2017, the Substance Abuse and Mental Health Services Administration (SAMHSA) published a final rule on Confidentiality of Substance Use Disorder Patient Records. That rule is scheduled to take effect on February 17, 2017. In accordance with the memorandum of January 20, 2017, from...
View this on Federal Register >


------------------------------
Julie Sours, MHA, CPCO, HCISPP
Senior Associate, Information Security and Privacy
Heartland Alliance for Human Needs and Human Rights
Chicago, IL

The views expressed herein are my own and do not represent those of my employer.
------------------------------



8.  RE: A couple of questions

Posted 5 days ago
Perfect! I remember seeing that the delay was until "no sooner than March 20, 2017" good to see that they have actually given the date. Thank you Julie.

------------------------------
David Rothery, CHC
Compliance Officer
Marin County, CA


These are my personal opinions and not those of the County of Marin
------------------------------



9.  RE: A couple of questions

Posted 5 days ago
I was just thinking about this earlier and wondered if it ever became final. I am trying to keep this one on my radar too. 

------------------------------
Julie Sours, MHA, CPCO, HCISPP
Senior Associate, Information Security and Privacy
Heartland Alliance for Human Needs and Human Rights
Chicago, IL

The views expressed herein are my own and do not represent those of my employer.
------------------------------



10.  RE: A couple of questions

Posted 5 days ago

Hi Donna,

I'm going to take a stab at answering this in the hopes that other will respond as well. 

Q: Can anyone simplify what is meant by a conditioned authorization and an unconditioned authorization for research example?  I know that the authorizations can now be combined ... But I really do not know what is meant by conditioned and unconditioned.  Any simplification would be appreciated!

A: I would take this to mean that if the CE  has an conditional authorization for the subject to sign that is in addition to the informed consent, the CE is seeking a conditional authorization for the use/disclosure of the subjects PHI. The subject would be excluded from the research study due to their refusal to sign the authorization. It is a condition to participate in the research study.  

The unconditioned is explained below in section 4.  It states that in section one that a CE may add a condition, but not necessarily. 


(3) Compound authorizations. An authorization for use or disclosure of protected health information may not be combined with any other document to create a compound authorization, except as follows:

(i) An authorization for the use or disclosure of protected health information for a research study may be combined with any other type of written permission for the same or another research study. This exception includes combining an authorization for the use or disclosure of protected health information for a research study with another authorization for the same research study, with an authorization for the creation or maintenance of a research database or repository, or with a consent to participate in research. Where a covered health care provider has conditioned the provision of research related treatment on the provision of one of the authorizations, as permitted under paragraph (b)(4)(i) of this section, any compound authorization created under this paragraph must clearly differentiate between the conditioned and unconditioned components and provide the individual with an opportunity to opt in to the research activities described in the unconditioned authorization.

This was also mentioned above and I thought I would in include due to its relevance. 164.508 (b)(4)(i)

(4) Prohibition on conditioning of authorizations. A covered entity may not condition the provision to an individual of treatment, payment, enrollment in the health plan, or eligibility for benefits on the provision of an authorization, except:

(i) A covered health care provider may condition the provision of research-related treatment on provision of an authorization for the use or disclosure of protected health information for such research under this section;



------------------------------
Jackie Robertson-Gutshall
Compliance Officer
Advanced Regional Center
Altoona,PA
------------------------------