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Post by respect on Dec 12, 2012 20:43:08 GMT -5
I guess the CROs are now becoming lab rats for the bigger prize-the millions in funding for bragging rights of having a head start in electronic data management in the health field. This comes with serious downside for the CROs, a potential stampede of law suits for HIPAA infringements. Its just a matter of time before other entities realize the potential damage these verified programs may have on privacy concerns of the larger population and collaborative effort to protect individuals privacy gain moment. I think we are going to see this interest being litigated in 2013.
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Post by respect on Dec 9, 2012 12:47:40 GMT -5
You are definitely on to soing. This appears as pilot program that set these verification companies up for an electronic file sharing advantage. Essentially at the clinical stage they are using us as lab rats for their larger agenda.
Here is the difference though. When your doctor request permission to release your information its done without coercion or inducement which is clearly supported by HIPAA rule. The same can not be said about these cerification protocol. If you wish not to seed your HIPAA rights you are not allowed to do the study. That in itself to me suggest coercive force and warrants scrutiny under HIPAA. The inducement is if you give up your HIPAA rights even though you dont want to the inducement is the payment receive from participating in the study.
Because of the larger implications these verification process deserve the more scrutiny of the public and the courts because of evolving consequence if these programs are allowed to move forward.
To make another point these programs may jeopardize individuals participating in stages II,III and IV. Some of you have been in CROs where individuals with life threatening illnesses are participating in clinical research. If these patients are aware of the existence of these databases they may be less likely to enroll in these CROs further undermining scientific advancement. The economic viability of such clinics may be undermined as such individual shift to CROs that are mindful of their concerns. That inturn undermine abilities of CRO with these veri programs to ue to perform phase 1 because funding for the other phase trials have been jeopardized.
In my best opinion these programs should be suspended and until further input from all the stake holders and until definitive opinion is handed down from the courts.
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Post by respect on Dec 8, 2012 9:35:47 GMT -5
How to get your voice heard! Let the medical staff know you think that your HIPAA rights are being violated! If every participant who walks into the exam room tells the doctor of his concern it moves the obligation away from the larger organization to individuals. Most doctors and certainly nurses are uncomfortable in any infringement in this area and particularly privacy is their concern. They also may care more than the profit sharks in corporate. They also have to answer to Medical Boards.
Their actions or in actions here may offer guidance in how they approach HIPAA sensitive situations in their private practice, hospitals and board they sit on.
The medical board in the state where that is a part of the CRO needs to be made aware of the verification HIPAA umbrella under which that doctor practices and explore violations of the HIPAA rules.
That brings up another point if you think your HIPAA rights are being violated bring the issue up with your personal doctor. Your doctor has your interest at heart much more so than a for profit CRO. They are much more likely to tell you how to proceed to protect your HIPAA rights.
When you get help share with your associates(they call us subjects) so that get they can get the assistance they deserve. Remember the Obama theme song. We take care of our OWN.
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Post by respect on Dec 7, 2012 21:47:03 GMT -5
What are the penalties if an organization fails to comply with the HIPAA Privacy Rule? Failure to comply with the HIPAA Privacy Rule may result in civil or criminal penalties. HIPAA’s civil penalties were increased by the HITECH Act but may not apply if the violation is corrected within 30 days. For violations in which the individual is not aware that the violation has occurred, the minimum penalty remains $100 per violation, up to $25,000 per calendar year for identical violations. If the violation is due to reasonable cause, the minimum penalty is $1,000 per violation, up to $100,000 per calendar year. For corrected violations that are caused by willful neglect, the minimum penalty is $10,000 per violation, up to $250,000 per calendar year. The maximum civil penalty for any type of violation and the minimum penalty for uncorrected violations caused by willful neglect is $50,000 per violation, up to $1.5 million per calendar year for identical violations. The criminal penalties are: •$100 per violation, up to $25,000 per year, per standard, for disclosures made in error. •$50,000 and/or one year in prison for knowingly obtaining or disclosing PHI. •$100,000 and/or up to five years in prison for obtaining information under false pretenses, and $250,000 and up to 10 years in prison for obtaining PHI with an intent to sell, transfer, or use it for commercial advantage, personal gain or malicious harm. Taking the time to understand the rules will ensure that your organization is complying as it should under the law. Jessica Galardini is president and COO of JRG Advisors, the management arm of ChamberChoice. Reach her at (412) 456-7231 or jessica.galardini@jrgadvisors.net.
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Post by respect on Dec 6, 2012 23:06:55 GMT -5
HIPAA rules were designed to protect you. Any entity or individual that think otherwise should be beware. Clinical Verification like anything must stand the test of the law. We should have full access to how and the content of our info are being shared. And we would should not be by any means coerced to forfeit our rights via threat or inducement. For a start make sure to keep a copy of all forms that you sign that may evidences infringement of such rights and that includes the consent form that may say if you do not allow the verification process you can not do the study under PI(doctors) care. Present these copies to organizations and lawyer(s) who have an interest in protecting your rights. Many lawyers give free first consultation and may be interested in offering their services pro bono especially if allowed to represent a group. Lawyers helps you focus on the parties that may be in violation of HIPAA rules. Is it the CRU and/or Sponsor and/or IRB and/or verification company or simply all of the above. They may even through the legal process make all potential parties that are subject to such processes made aware of potential violations of rights. Dont be scared HIPAA prevents organization from retaliating against individual(s) who complain about their rights being violated. If its makes you more comfortable approach lawyers or organizations with a friend or group its adds an urgency and will make others comfortable making the move. I took the time to provide a link to pursue complaints not excluding the above suggestions. www.hhs.gov/ocr/privacy/hipaa/complaints/index.html
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