From mmreturn@magnetdev.com Tue Dec 29 09:05:37 2009 Return-Path: Received: from mail35.magnet101.com (mail35.magnet101.com [209.18.93.35]) by smtp.XXXXXXX.XXX (8.14.3/8.14.3) with ESMTP id nBTH5XCF031388 for ; Tue, 29 Dec 2009 09:05:36 -0800 Message-Id: <200912291705.nBTH5XCF031388@smtp.XXXXXXX.XXX> Received: from MAGNETMAIL4 (172.17.35.4) by mail35.magnet101.com id h78re00ir9c7 for ; Tue, 29 Dec 2009 12:05:32 -0500 (envelope-from ) Date: Tue, 29 Dec 2009 12:05:31 -0500 From: editor@principalinvestigators.org To: Subject: Your Issue: December 29, 2009 X-TokenInfo-NoToken: X-Bps1: 4620618395 MIME-Version: 1.0 Content-Type: multipart/alternative; boundary="_NextPart_000_896352_20091229_12530624" X-Proofpoint-Virus-Version: vendor=fsecure engine=1.12.8161:2.4.5,1.2.40,4.0.166 definitions=2009-12-29_15:2009-12-12,2009-12-29,2009-12-29 signatures=0 X-Proofpoint-Spam-Details: rule=notspam policy=default score=0 spamscore=0 ipscore=0 phishscore=0 bulkscore=100 adultscore=0 classifier=spam adjust=0 reason=mlx engine=5.0.0-0908210000 definitions=main-0912290100 --_NextPart_000_896352_20091229_12530624 Content-Type: text/plain; charset="ISO-8859-1" Content-Transfer-Encoding: quoted-printable PI e-Alert features expert advice on managerial and administrative challeng= es which confront Principal Investigators in every field of science researc= h.=20 No. 9, December 28-January 1, 2009-2010 Research Compliance: Lost Data? Reader Question:=A0=A0 A month ago I was flying to a convention of my research specialty in San Fr= ancisco, and in one of my checked bags was my notebook computer and three d= iscs of raw data (non-encrypted) on about 800 patients we have enrolled in = a clinical trial. But the airline lost the bag in transit. Of course, I fi= led a "lost bag" claim with them, but no trace of it yet. Little hope now. = I have heard there is some new law called HITECH that applies to lost data.= What should I do at this point? Should I already have done anything? = =20 Expert Comments:=A0 Brace yourself, we're going to have to deal with some "alphabet soup" of U.= S. government acronyms while explaining your situation.=20 The Health Information Technology for Economic and Clinical Health Act, or = HITECH, is the U.S.A. Federal law that requires you take immediate action a= nd notify those affected by a loss of protected health information (PHI). =20 First, figure out if HITECH applies. In order for it to come into play, HIP= AA (Health Insurance Portability of Accountability Act of 1996) has to appl= y to you. It does if you're working with patients. However, does HIPAA appl= y to the particular data you've lost? If you took all of the identifiers of= f the data, then you're ok because de-identified data isn't covered by HIPA= A or HITECH. But maybe you aren't so lucky, and the data contained the initials of patie= nts and their diagnoses. Remember, even initials are identifiers under HIP= AA. If the bag stays gone, HIPAA's in play, but not necessarily HITECH. Was= that data encrypted? If so, HITECH's breach notification rules View the remainder of the expert comments at XXXXXXXprincipalinvestigators.= org/news.php Comments by=A0Kristen H. WestJ.D., Associate V.P. and Director, Office of R= esearch Compliance, Emory University Atlanta Agree? Disagree?=A0Submit your comments at XXXXXXXprincipalinvestigators.o= rg/news.php =20 ??Preview of Next Week's Question?? No. 10, January 4-8, 2010 Reader Question:=A0 One of my lab techs wants to transfer to another lab on our campus. Its PI= happens to be a good friend of mine. The employee wants me to provide a g= ood reference, but truth is she is irresponsible and I'm glad to get rid of= her. Do I dare write my colleague the truth about his prospective hire? W= ould I risk being charged with defamation? What about merely "whispering" = the situation to him over a drink? Submit your early-bird comments at XXXXXXXprincipalinvestigators.org/news.p= hp =20 Missed Last Weeks's Question?=20 Reader Question:=20 Do the reviewers look at the budget, and is it taken into account as a revi= ew criterion? How does one ensure that a budget will be viewed as realisti= c?=20 View the expert comments at XXXXXXXprincipalinvestigators.org/news.php =20 Don't miss January's featured audio conference "Writing Successful Proposal= s". For more information, visit XXXXXXXprincipalinvestigators.org/audio_con= ference_0110.php This issue was brought to you as a service by=A0Principal Investigators Ass= ociation. If you have general questions or comments contact us at=A0editor@= principalinvestigators.org. * Please note that in some cases the unsubscribe links in these messages ca= n become broken by the way that an email program displays the message. If y= ou are having trouble unsubscribing you may also forward this message to un= subscribe@principalinvestigators.org with the word 'remove' in the email me= ssage subject line. Principal Investigators Association=A0 3565 10th St N, Suite B Naples, FL 34103 USA (800) 303-0129=0A=0D****************************= ********************************** =0A3565 10th Street N, Naples, FL 34103= =0A**************************************************************=0AUse t= his link to unsubscribe: XXXXXXXwww.magnetmail.net/Actions/unsubscribe.cfm?message_id=3D896352&user_= id=3DPRININVEST&recipient_id=3DXXXXXXXXX&email=3DXXX@XXXXXXXX.XXXXXXX.XXX&gro= up_id=3D421269 --_NextPart_000_896352_20091229_12530624 Content-Type: text/html; charset="ISO-8859-1" Content-Transfer-Encoding: quoted-printable PI e-ALERT

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PI e-Alert <= font face=3D"sans-serif" style=3D"font-size: 7pt">features expert=20 advice on managerial and administrative challenges which confront=20 Principal Investigators in every field of science research.=20 If such matters are not of interest to you or your associates,=20 please accept our apologies and "unsubscribe" at the bottom of=20 the page.


No. 9, December 28-January 1, 2009-2010

Research Comp= liance:

Lost Data?<= /font>

Reader Question:=A0=A0A month ago I was flying to a convention of my research s= pecialty in San Francisco, and in one of my checked bags was my notebook co= mputer and three discs of raw data (non-encrypted) on about 800 patients we= have enrolled in a clinical trial. But the airline lost the bag in transi= t. Of course, I filed a "lost bag" claim with them, but no trace of it yet.= Little hope now. I have heard there is some new law called HITECH that app= lies to lost data. What should I do at this point? Should I already have d= one anything? =20

Expert Comments:=A0Brace= yourself, we're going to have to deal with some "alphabet soup" of U.S. go= vernment acronyms while explaining your situation.

The Health Information Technology for Eco= nomic and Clinical Health Act, or HITECH, is the U.S.A. Federal law that re= quires you take immediate action and notify those affected by a loss of pro= tected health information (PHI).

=20

First, figure out if HITECH applies. In o= rder for it to come into play, HIPAA (Health Insurance Portability of Accou= ntability Act of 1996) has to apply to you. It does if you're working with = patients. However, does HIPAA apply to the particular data you've lost? If = you took all of the identifiers off the data, then you're ok because de-ide= ntified data isn't covered by HIPAA or HITECH.

But maybe you aren't so lucky, and the d= ata contained the initials of patients and their diagnoses. Remember, even= initials are identifiers under HIPAA. If the bag stays gone, HIPAA's in pl= ay, but not necessarily HITECH. Was that data encrypted? If so, HITECH's br= each notification rules

View the remainder of the expert comments

Comments by=A0Kristen H. West, J.D.= , Associate V.P. and Director, Office of Research Compliance, Emory Univers= ity Atlanta

Agree? Disagree?=A0Submit your comments

=A0

=A0

??Preview of Next Week's Question??=

No. 10, January 4-8, 2010

Reader Question:=A0O= ne of my lab techs wants to transfer to another lab on our campus. Its PI = happens to be a good friend of mine. The employee wants me to provide a go= od reference, but truth is she is irresponsible and I'm glad to get rid of = her. Do I dare write my colleague the truth about his prospective hire? Wo= uld I risk being charged with defamation? What about merely "whispering" t= he situation to him over a drink?


3D"Early-bird=A0=A0= =A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0 =A0=A03D"Submit



=

Missed Last Weeks's Question?

Reader Question: Do the reviewers look at the grant application budget, and is it= taken into account as a review criterion? How does one ensure that a budg= et will be viewed as realistic?

=20

View t= he expert comments


Don't miss January's featured audio conference "Writing Successful Proposals":3D"AC



3D"Subscribe"


This issue was brought to you as a se= rvice by=A0Principal Investigators Association. If you have genera= l questions or comments contact us at=A0editor@principalinvestigators.org.

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