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BHC Orthopaedic Registry
Established 1997 on BHC network to improve:
1) Access2) Security3) Backup4) Support5) HIS Integration6) Input load sharing
BHC Orthopaedic Registry
Direct physician point-and-click data entry to:1) improve data specificity & consistency for research 2) codify data for practice management & certification3) provide “just-in-time” alerts and CME4) reduce data collection redundancy & cost
HIPAA Calls3/27/2007
Concerns about security
No computer system is secure.
Business Associate Agreement (BAA) - 4/12/2007
Bellevue HIPAA requires a Bellevue BAA
until then
BELLEVUE ORTHO DATABASE ACCESS DENIED
Business Associate AgreementIndemnification Clause
”The Business Associate must agree to indemnify, defend, and hold harmless Bellevue Hospital and all of its … workforce against all losses suffered and all liability to third parties arising from or in connection with any material breach of this Agreement by the Business Associate.”
Liability insurance - unaffordable
BELLEVUE ORTHO DATABASE ACCESS DENIED
Business Associate AgreementIndemnification Claws
BHC Ortho Dept - 6/1/2007“We’ve got you covered.”
“I used to be a doctor,
then I was a provider,
now, I'm a
COVERED ENTITY”
William De Alva, M.D. Tucson, AZ
New BHC HIPAA Strategy:Move Goalposts - Play for Time
DataBase Clearances Required:
1) NYC HHC Legal 2) NYC HHC Research3) NYU SOM IRB4) MSSM IRB
until then
DATABASE ACCESS DENIED
One Year Later
• I am a covered entity within a covered entity.• Database has HHC Legal Office Review• Database has NYU IRB Clearance• Database has NYC HHC Research Office
Clearance• Database has DHHS OHRP Clearance
BELLEVUE ORTHO DATABASE ACCESS DENIED
HIPAA Says:You may have a Virus
Administrative VPN Access Denied
It’s OK if you sign a BAA
Liability Insurance - unaffordable
“You don’t have the funds to be on the playing field.”
DATABASE ACCESS DENIED
The Bottom Line
HIPAA appears to be much more concerned about the protection of the institution and its officers - rather than the privacy of patients and the quality of their care.
Eugene H. Spafford
“Data is not necessarily information.
Information does not necessarily lead to knowledge.
And knowledge is not always sufficient to discover truth and breed wisdom.”
NYU SoM IRB Findings 12/19/2007
• The Bellevue orthopaedic database is not research involving human subjects.
• The information does not require IRB review for human subjects research purposes or HIPAA purposes.
• The NYU SoM IRB does not consider Clinical Databases to be research data repositories.
NYC HHC Research Findings1/16/2008
• The NYU SoM IRB statement is accepted from an HHC Research Approval standpoint
• The OHRP DHHS regulations do not apply to the existing Bellevue Orthopaedic Department database