Posted January 26, 2012
To: My Privacy & HIT Students
During our January 23, 2012 class (with some of you being absent) we began a discussion of the just-decided and important Jones decision in which the US Supreme Court addresses many of the concerns that we will be addressing during our classroom discussions. Please study the Jones decision in anticipation of our discussion during our next class:
http://www.supremecourt.gov/opinions/11pdf/10-1259.pdf
In addition, we assigned specific decisions to specific students who were in attendance, for our discussion during our next class. Those who were not in attendance yesterday should please become familiar generally with all of the decisions assigned previously and with the Brandeis article cited in our syllabus, in addition to the Jones decision cited above.
More of your effort should please be dedicated to the Jones decision and to the Brandeis article and to the Sorrell decision.
Because of the fortuitous availability of the Jones decision, the written assignment for our next class, due by 11:59 PM on the evening before our class day, is changed. More specifically, those who were in attendance yesterday in class received new assignments relating specifically to a particular decision or the Brandeis article; those who were not in attendance yesterday in class should please change the written assignment to briefly to summarizing (points of interest are okay, narrative not mandatory) just the Jones decision and the Brandeis article in lieu of all the other decisions.
Further regarding our studies, here are some links that I hope will take you to some web sites that contain helpful information regarding privacy issues. We will talk more about this during our next class; all you need do is peruse each site for at least a few moments (of course you are free to linger) in order to have some beginning familiarity with each site; nothing has to be written as an assignment because the purpose of your visits to these cites simply is to provide you with helpful resources for your papers and for your general knowledge.
You might have to copy and paste each link in your browser address ribbon to avoid truncation difficulties or the absence of direct URL connectivity via each link below.
http://www.privacyrights.org/fs/fs8-med.htm
http://www.npr.org/series/ 114250076/the-end-of-privacy
http://www.cdt.org/issue/health-privacy
http://epic.org/privacy/
https://www.eff.org/issues/privacy
http://business.ftc.gov/privacy-and-security
http://www.facebook.com/about/privacy/
http://www.google.com/intl/en/privacy/
http://www.microsoft.com/en-us/healthvault/MicrosoftsPHRDataPracticesforHealthVault.aspx
Finally, regarding the term paper, please provide me with proposed topic(s) as soon as possible and preferably within the next couple of weeks. You also may accompany your topic(s) with a brief outline and preliminary list of resources for study and analysis; or you can elect to provide an outline/resources after your topic is approved. And the final paper due date will be 3 PM on April 9, 2012, please, via eMail to me.
Kindly advise me if you have any questions or concerns regarding all the foregoing. Thank you.
Posted January 17, 2012
To: My AU WCL Privacy & Health Information Technology Students
Please feel free to inquire regarding any questions you might have about what is posted below, so that I can address any questions regarding our initial several week period of classes. As indicated during our first class and particularly because some of my students for this course have a health background while others do not, and because each of my students has taken some health and other law courses but not others, and because some of my students have been employed or are employed now in health-related areas, it usually takes several weeks and two or three classes before we can determine how best to design our course in order to mazimize the opportunities to learn for everyone in the class, regardless of experience or employment. This process also will enable us to be more specific regarding how much of the list of relevant materials referenced below can be anticipated to be part of our curriculum and discussions. And as discussed in class, because of the substantial number of new developments that occur in privacy and health information technology, some substitutions of new developments for those previously referenced below likely will occur so that your educational experience can include learning about the most important new developments.
I look forward to being with you again on January 23, please.
Regards, Alan@GoldbergLawyer.com
Posted January 16, 2012
AU Wash. College of Law Privacy & HIT (LAW-719-002) Spring 2012
To: My AU WCL Privacy & Health Information Technology Students
Coming Attractions
Please know that we will be studying, inter alia, the following in the weeks after our second class and I will provide further information during our next class. But for now, feel free to begin to peruse the following and let me know if you have any difficulty accessing any of these materials please. We likely will not be able to address all of the following materials because of time limitations and because sometimes our classroom discussions take more time than might be anticipated. In addition, current events might cause us to change our focus from time to time as new developments occur.
Genetic information and life.
1. http://web.me.com/asgoldberg1/filechute/genepatents-USamicusbrief.pdf
2. http://web.me.com/asgoldberg1/filechute/genepatents-AMPvUSPTO-Opinion.pdf
3. http://graphics8.nytimes.com/packages/pdf/national/20100329_patent_opinion.pdf
Health care from a distance and information used.
4. http://web.me.com/asgoldberg1/filechute/mass%20board%20tissue%20nh%20ma%20pathology%20opinion.zip
Business method patents and health information.
5. http://www.supremecourt.gov/opinions/09pdf/08-964.pdf
6. http://www.law.berkeley.edu/files/inrebilski.pdf
Patientable process and health information.
7. http://www.bloomberglaw.com/public/document/Prometheus_Labs_Inc_v_Mayo_Collaborative_Servs_628_F3d_1347_97_US
Electronic contracts, eSignatures, and health information.
8. http://www.ftc.gov/os/2001/06/esign7.htm
9. http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=106_cong_public_laws&docid=f:publ229.106.pdf
eSign law, UETA, health information.
10. http://www.bankersonline.com/ebanking/ueta.html
11. http://www.law.cornell.edu/uscode/18/usc_sup_01_18_10_I_20_119.html
12. http://www.ncsl.org/default.aspx?tabid=13484
Health care fraud and abuse, and health information.
13. http://oig.hhs.gov/fraud/advisoryopinions.asp
[Advisory Opinions relating to HIT]
Advisory Opinion No. 99-14
Advisory Opinion No. 99-18
Advisory Opinion No. 10-04
Advisory Opinion No. 08-08
Advisory Opinion No. 08-12
Advisory Opinion No. 02-12
Advisory Opinion No. 08-19
Advisory Opinion No. 09-16
Advisory Opinion No. 04-04
Advisory Opinion No. 02-14
Advisory Opinion No. 08-01
Telemedicine and health care from a distance and health information.
14. http://www.americantelemed.org/files/public/abouttelemedicine/What_Is_Telemedicine.pdf
15. http://www.americantelemed.org/files/public/abouttelemedicine/Terminology.pdf
16; http://www.americantelemed.org/files/public/policy/Medicare_Payment_Of_Services.pdf
17. http://americantelemed.i4adev.com/files/public/abouttelemedicine/JCP_2_2_2003.pdf
18. http://www.americantelemed.org/files/public/policy/Licensure_Portability.pdf
19. http://www.americantelemed.org/i4a/pages/index.cfm?pageID=3311
20. http://www.hrsa.gov/telehealth/pubs/licensure.htm
21. https://www.cms.gov/Telemedicine/
22. http://www.cms.gov/officeoflegislation/downloads/NewRulestoEnsureAccesstoTelemedicineServices.pdf
24. http://web.me.com/asgoldberg1/filechute/prometh-010remand.pdf
Tissues and ownership.
25. http://web.me.com/asgoldberg1/filechute/washutissuecir-2007.pdf
26. http://www.connected-health.org/media/71068/telemed%20reimbursement%20policy.pdf
27. http://edocket.access.gpo.gov/2010/pdf/2010-12647.pdf
28. http://www.americantelemed.org/files/public/standards/Telepresenting_Draft_PublicComment.pdf
Electronic prescriptions.
29. http://www.deadiversion.usdoj.gov/fed_regs/rules/2010/fr0331.pdf
Health information technology and privacy and security: associations and standards.
30. http://www.ansi.org/internet_resources/overview/overview.aspx?menuid=12#national
31. http://www.consortiuminfo.org/links/linkscats.php?ID=48
32. http://www.nist.gov/index.html
33. http://www.ahima.org/
34. http://www.wedi.org/
35. http://www.cio-chime.org/
36. http://www.himss.org/ASP/index.asp
37. http://www.hl7.org/
38. http://www.iso.org/iso/home.html
39. http://www.ansi.org/
40. https://www.amia.org/
Health Insurance Portability and Accountability Act of 1996 (HIPAA).
41. http://aspe.hhs.gov/admnsimp/pl104191.htm
42. http://web.me.com/asgoldberg1/filechute/HITECH%20Pages%20from%20PLAW-111publ5.pdf
43. http://www.hhs.gov/ocr/privacy/hipaa/administrative/combined/index.html
44. http://www.hhs.gov/ocr/privacy/hipaa/administrative/privacyrule/adminsimpregtext.pdf
45. http://www.hhs.gov/ocr/privacy/hipaa/administrative/index.html
46. http://web.me.com/asgoldberg1/filechute/electsighipaa1998.pdf
47. http://www.hhs.gov/ocr/privacy/hipaa/administrative/securityrule/securityrulepdf.pdf
Health information security.
48. http://csrc.nist.gov/publications/drafts/800-144/Draft-SP-800-144_cloud-computing.pdf
49. http://csrc.nist.gov/publications/drafts/800-145/Draft-SP-800-145_cloud-definition.pdf
50. http://csrc.nist.gov/publications/drafts/800-70-rev2/Draft-SP800-70r2.pdf
51. http://www.hhs.gov/ocr/privacy/hipaa/administrative/securityrule/nist80066.pdf
52. http://web.me.com/asgoldberg1/filechute/washutissuecir-2007.pdf
53. http://web.me.com/asgoldberg1/filechute/prometh-010remand.pdf
133616012012
Term Paper and Grading
Your grade for our course will be determined by my evaluation of your term paper, your compliance with occasional memoranda submission requirements, and your class attendance and participation. There is no final examination for our course.
The term paper will be required to be at least ten sheets in length (8-1/2 by 11 paper size, 12 point typeface, double spacced) but can exceed that number of sheets if you so choose, and footnotes/citations are in addition to the minimum length requirement. We will discuss topics and other aspects of your term paper during our next class, including the due date and paper presentations and discussions.
Occasional memoranda submissions are referenced below and addendance and participation will be discussed during our next class.
Posted January 11, 2012
To: My HIT/Privacy Law Students
Good day. Here is the description of our course, for your ready-reference. How much of the course content referenced below we will be able to include in our class discussions will depend upon our progress and new developments.
Health care is a heavily regulated profession and industry, but some believe that federal and state regulation has not successfully provided adequate protection for health information. An important part of the regulatory process includes issues implicated by privacy and confidentiality, security, and data breach concerns, particularly when sensitive individually identifiable health information is created, stored, used, and disclosed, and subjected to data mining. Health care delivery and payment, and associated biomedical research and innovations have emerged as a growing part of health care with much more information being created, and radical changes in the way the ever growing amount of health information is used and in the minds of some, sometimes abused, despite applicable laws, is a growing concern. Included in areas of substantive concern are the Administrative Simplification Subtitle of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as amended, the Health Information Technology for Economic and Clinical Health (HITECH) Act enacted as part of the American Recovery and Reinvestment Act of 2009, the Genetic Information Nondiscrimination Act of 2008 (GINA), the Patient Safety and Quality Improvement Act of 2005 (PSQIA), and the Patient Protection and Affordable Care Act (referred to as PPACA or the Affordable Care Act or the health reform law), and certain state laws, as well as the European Data Protection Directive and relevant laws of foreign nations. The emerging area of life sciences law and related federal Food and Drug Administration regulatory and information use and disclosure concerns,including software as a medical device and mobile health, sometimes referred to as mHealth, involve many fascinating issues that are publicized heavily in the media and implicate complex legal issues relating to genetics and genomics, and privacy and security. Privacy and confidentiality, security, health information technology, electronic medical and health care records, using information in research including stem cell research and ownership of information, data mining and marketing, telemedicine and eHealth, and other relevant topics relating to health care generally and the life sciences specifically, will be considered.
For your first study assignment in anticipation of our class scheduled for January 23, 2012, please visit the statutory laws and regulatory promulgations for the state jurisdiction to which you are admitted as an attorney-at-law or if you are admitted to several, select your favorite; if you are not yet admitted to the bar, please use the law of the state that you most likely will want to be admitted to; and if you have lived abroad, you may select the law of the nation abroad (France, Spain, et al...) you prefer to select. Your assignment is to determine what law(s) and regulation(s) define the practice of medicine and health care under the applicable laws of the state (or DC) or the nation selected.
In addition, your assignment is to visit the United States Code, and to determine where in the statutory law of the United States of America there are definitions of the practice of medicine, and health care (if there are too many, select what you believe to be the most important, in your judgment). Please also visit the Constitution of the United States of America as amended for your analysis regarding your search for the relevant words and concepts.
Sometimes the words used might be different: that is, instead of the practice of medicine, you might see the practice of medicine and surgery; and instead of health care, you might see healthcare or health; do the best you can, however, to focus on the the overall purpose of your analysis, which is to determine how the laws you are researching define the concepts of each of the practice of medicine, and health care, regardless of the particular words used.
Please do the same type of analysis for the word privacy and the word confidentiality, and if possible limit your analysis to practice of medicine, and to health care, contexts; but if that is not possible, feel free to go beyond those particular contexts.
Your written assignment, due by 11:59 PM on the evening before our next class, via email to me is to summarize the results of your research referenced above, please, with appropriate citations (Blue Book or other generally accepted standard will be acceptable). Feel free to limit your written submission to what would be three to five sheets of 8-1/2 by 11 inch paper but feel free to provide more information if you prefer. Submit either or both of .doc/WinWord and .pdf files, please, attached to your email.
In addition, please begin your study of the article and the judicial decisions identified below (I have provided links that I have found to be active but feel free to study these materials using other linked web sites or Lexis or Westlaw if that is more convenient for you).
We will begin discussing the materials referenced below toward the end of our second class and therefore please study as much of the following materials as you can if you want to prepare further ahead of our detailed discussion. Our discussion will continue during our third class. Your written assignment for the third class, due by 1:59 PM on the evening before that class, will be briefly to summarize (narrative not required, outline format will be satisfactory) the salient points implicated by the following assigned readings, please. Again, three to five sheets would be acceptable but more including narratives would be accepted as well.
ASSIGNED READINGS:
1. “The Right to Privacy” - Warren and Brandeis - Harvard Law Review. - Vol. IV December 15, 1890 No. 5
available at:
http://groups.csail.mit.edu/mac/classes/6.805/articles/ privacy/Privacy_brand_warr2.html
2. ROE v. WADE, 410 U.S. 113 (1973)
available at
http://caselaw.lp.findlaw.com/cgi-bin/getcase.pl?court=us& vol=410&invol=113
3. OLMSTEAD v. U.S., 277 U.S. 438 (1928)
available at:
http://caselaw.lp.findlaw.com/cgi-bin/getcase.pl?court=us& vol=277&invol=438#478
4. WILLIAM H. SORRELL, AS ATTORNEY GENERAL OF THE STATE OF VERMONT et al. v. IMS HEALTH INC. et al. including Petition for Writ of Certiorari
available at:
http://sblog.s3.amazonaws.com/wp-content/uploads/2010/12/Pet .10-779.pdf
available at:
http://www.supremecourt.gov/opinions/10pdf/10-779.pdf
5. KATZ V. UNITED STATES, 389 U. S. 347 (1967)
available at: http://supreme.justia.com/us/389/347/case.html
6. UNITED STATES of America, Appellee v. Lawrence MAYNARD, Appellant [United States v. Jones before US Supreme Court]
available at:
Kindly advise if any of the links provided above are inoperative. I soon will post this email at my web site
http://www.healthlawyerblog.com
where it might be easier simply to click through to the linked web site pages (sometimes email links become truncated or otherwise don't function).
Before our third class and after I complete my review of your CVs, a full term syllabus will be published, subject to change as further developments occur in our areas of focus.
Finally, a separate email will follow soon regarding the term paper and relevant details, including topics, length and style, and more.
Please feel free to inquire of me via email if you have questions about any of the foregoing or anything else regarding our course.
Thank you and welcome to our course.
Alan S. Goldberg
http://www.healthlawyerblog.com
ASG/tt 120111012012
To: My AU WCL Privacy & HIT LLM Law Students
