HEALTHLAWYER

AU Wash. College of Law Privacy & Health Information Tech. (LAW-719-002) Feb. 14, 2011 class

For our February 14, 2011 class, please study the the Genetic
Information Nondiscrimination Act of 2008 and background information
regarding the statute referenced at the hot linked pages below:

1.    http://www.genome.gov/24519851

2.    http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ233.110

3.    http://www.gpo.gov/fdsys/pkg/BILLS-110hr493enr/pdf/BILLS-110hr493enr.pdf

4.    http://www.genome.gov/Pages/PolicyEthics/GeneticDiscrimination/GINAInfoDoc.pdf

5.    https://rarediseases.info.nih.gov/GARD/GINA/

6.    http://www.hhs.gov/ocr/privacy/hipaa/understanding/special/genetic/

7.    http://www.genome.gov/10002077

8.    http://www.hhs.gov/news/press/2009pres/10/20091001b.html

9.    http://www.hhs.gov/ocr/privacy/hipaa/understanding/special/genetic/ginanprm.pdf

and familiarize yourself with the general background and health law
context for and implications of the enactment of the statute with
emphasis on privacy and security.  More particularly, please determine
which parts of the statute relate specifically to health information
technology and to electronically stored information, and to health
care privacy and security as well, and study the rule-making
compliance implications including the proposed rule published by the
Office for Civil Rights.

Special assignment: please review the foregoing hot linked web sites
and in particular GINA 2008 and the NPRM from OCR.  Based upon all the
foregoing, please prepare a chart and an analysis of how GINA 2008
affects and protects (and/or does not affect and protect, depending
upon your views and analysis) health information privacy and security
including what the NPRM proposes, which may include a narrative
summary.  Be prepared, please, to discuss how you would propose
further to enhance privacy and security relating to genomic and
genetic information and what you may perceive as challenges created by
GINA 2008 with respect to potential research implications and
limitations and complexities in compliance and enforcement, in the
context of privacy and security issues implicated.

Special assignment to be submitted prior to 11:59 PM on February 13, 2011 in
WinWord .doc and/or Adobe .pdf formats.

Please know that as usual and depending upon how our classroom
discussions proceed, our discussion of GINA 2008 might not occur
entirely on the expected February 14 date.  But nevertheless, the
special assignment is due as noted above, please.   

AU Wash. College of Law Privacy & Health Information Tech. (LAW-719-002)

To: My AU WCL students.  For our January 31, 2011 class, special assignment: please review the several previously assigned judicial decisions and the certiorari petition relating to pharmaceutical data mining and privacy which was a part of the assignment, and please study the statutes of the several states involved in the disputes.  Based upon the foregoing, please prepare a chart and an analysis of each position as reflected in the decisions (including plaintiffs, defendants, and judicial majority and dissents), which may include a narrative summary, of the opposing parties for and against the data mining statutes in the several states that are the subject of these decisions.  Be prepared, please, to discuss how you would propose to resolve the disagreement among the circuits if you were the tenth justice appointed to the United States Supreme Court.

Special assignment to be submitted via eMail to Alan@GoldbergLawyer.com prior to 11:59 PM on January 30, 2011 in WinWord .doc and/or Adobe .pdf formats.

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In anticipation of and to prepare for our February 7, 2011 class during which we will consider some FDA implications for eHealth including software, please study:

1.         http://www.fda.gov/downloads/.../Guidances/ucm126955.pd

2.http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm073778.htm

3.           http://medical.cms.itri.org.tw/pdf/u23.pdf

4.http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077812.htm

5.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/detail.cfm?id=22436

6.http://www.fda.gov/downloads/ForIndustry/SmallBusinessAssistance/SmallBusinessGuidetoFDA/UCM081030.pdf

7.         http://www.fda.gov/AboutFDA/WhatWeDo/default.htm

8.http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm085281.htm

9.    http://web.me.com/asgoldberg1/filechute/shurenfdaemrtestimonyemrrisks2010.pdf

10.   http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm239448.htm

For our February 7, 2011 class, special assignment: please review the FDA materials referenced above and prepare a chart and an analysis of if, how, and to what extent the FDA regulates medical software as a device or otherwise, which may include a narrative summary, and determine whether, and if so, how, the new FDA Plan of Act for Section 510(k) and Science affects the foregoing, please.  And be sure to determine what Section 510(k) provides and consider what the changes could implicate with respect to privacy and health information technology.

Special assignment to be submitted prior to 11:59 PM on February 6, 2011 in WinWord .doc and/or Adobe .pdf formats.

 

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AU Wash. College of Law Privacy & Health Information Tech. (LAW-719-002)

To: My AU WCL LLM Law Students

Your assignment for study for our January 24, 2011 class appears below.  No class is scheduled for January 17, 2011.

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1.         http://caselaw.findlaw.com/summary/opinion/us-2nd circuit/2010/11/23/252944.html  

    IMS HEALTH INC LLC v. SORRELL

IMS HEALTH INC., Verispan, LLC, et al., Plaintiffs-Appellants, v. William H. SORRELL, as Attorney General of the State of Vermont et al., Defendants-Appellees. Docket Nos. 09-1913-cv(L), 09-2056-cv(CON).

 

2.         http://www.ca1.uscourts.gov/cgi-bin/getopn.pl?OPINION=08-1248P.01A

United States Court of Appeals For the First Circuit No. 08-1248

IMS HEALTH INCORPORATED, VERISPAN, LLC, and SOURCE HEALTHCARE ANALYTICS, INC., a subsidiary of WOLTERS KLUWER HEALTH, INC.,

Plaintiffs, Appellees,

v.

JANET T. MILLS, as Attorney General for the State of Maine, Defendant, Appellant.

ON APPEAL FROM THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MAINE [Hon. John A. Woodcock, Jr., U.S. District Judge]

 

3.         http://epic.org/privacy/imshealth/dist_ct_op.pdf

United States Court of Appeals For the First Circuit No. 07-1945 IMS HEALTH INC. AND VERISPAN, LLC, Plaintiffs, Appellees, v. KELLY A. AYOTTE, NEW HAMPSHIRE ATTORNEY GENERAL, Defendant, Appellant.

APPEAL FROM THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW HAMPSHIRE [Hon. Paul J. Barbadoro, U.S. District Judge]

 

4.         http://openjurist.org/print/566777 428 F3d 167 Citizens for Health v. O Leavitt US

CITIZENS FOR HEALTH, et al. Appellants v.*Michael O. LEAVITT, Secretary U.S. Department of Health and Human Services. No. 04-2550. United States Court of Appeals, Third Circuit.

 

5.      http://supreme.justia.com/us/429/589/case.html

WHALEN V. ROE, 429 U. S. 589 (1977) 

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Please consider the MMA, MIPPA, and ARRA electronic prescribing and electronic health records and meaningful use incentives and requirements provisions, relative to health information creation, storage, access, use, and communications including pharmaceutical prescription information and any specific privacy and security protections affecting the foregoing.  See the following background information. 

Special assignment to be submitted via eMail to Alan@GoldbergLawyer.com prior to 11:59 PM on January 23, 2011 in WinWord .doc and Adobe .pdf formats.

Prepare a list and brief descriptions of the relevant federal statutes and regulations promulgated thereunder to-date.  You may use a narrative or chart configuration for this assignment.

6.         https://www.cms.gov/EPrescribing/01_Overview.asp#TopOfPage

7.         https://www.cms.gov/EHRIncentivePrograms/

8.        https://www.cms.gov/ERXIncentive/

9.        http://healthit.hhs.gov/portal/server.pt?open=512&objID=1153&mode=2

10.      http://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov__privacy_and_security/1147