Suffolk University Law School eHealth 2005

Suffolk University Law School eHealth 2005

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Last updated March 24, 2005

For our class scheduled for January 19, 2005 at 6 PM, the assignment is as follows:
Find and read the provisions of the statutes in your assigned jurisdictions that address the practice of medicine definitions, and telemedicine and other distance and technologies health care delivery approaches.

Recall please our Privacy Policy for this course:

Everything we say during this course is public.
Nothing we say during this course is private.
We have no privacy in this course.
Get over it!
(with acknowledgement of >Scott McNealy's inspiration for this policy)

For our class scheduled for January 26, 2005 at 6 PM, the assignment is as follows:

1. Go to >http://www.fsmb.org and click the link on the left side upper portion of the home page to get to Policy Documents (the linked page is A Summary of Federation Policy Documents), and then locate and read:
a. Report of the Ad Hoc Committee on Telemedicine, A Model Act to Regulate the Practice of Medicine Across State Lines
b. Report of the Special Committee on Professional Conduct and Ethics, Model Guidelines for the Appropriate Use of the Internet in Medical Practice
c. Report of the Special Committee on License Portability.

2. Please also read Massachusetts Board of Registration in Medicine Interstate Pathology Opinion September 18, 1995, which can be downloaded from a link on my Web site, using the link >Massachusetts Board of Registration in Medicine Interstate Pathology Opinion September 18, 1995

3. In addition, read the >Massachusetts Board of Registration in Medicine Policy on Internet Prescribing

4. Also read the materials linked at the >National Council of State Boards of Nursing Web site regarding the Nurse Licensure Compact and also the >Utah law materials relative to the same, including the >Nurse Licensure Compact, 58-31c

5. Although not yet assigned for class but mentioned during our January 19, 2005 class as a coming attraction, feel free to peruse

>Collaborative ONCHIT RFI Response
Collaborative Response submitted by: American Health Information Management Association (AHIMA), American Medical Informatics Association (AMIA), American National Standards Institute-Healthcare Informatics Standards Board (ANSI HISB), Center for Information Technology Leadership (CITL), Connecting for Health (CFH), eHealth Initiative (eHI), HIMSS EHR Vendor Association (EHRVA), Healthcare Information and Management Systems Society (HIMSS), Health Level Seven, Inc. (HL7), Integrating the Healthcare Enterprise (IHE), Internet2, Liberty Alliance, National Alliance for Health Information Technology (NAHIT)
relating to >HHS National Health Information Infrastructure

For our class scheduled for February 9, 2005 at 6:30 PM, the assignment is as follows (which includes catch-up materials from our storm-cancelled January 26th class assignment):

1. Read Mario L. Shannon et al. v. Larry P. McNulty, M.D. et al, 718 A.2d 828, 1998 Pa. Super. LEXIS 2823, October 5, 1998

and >Managed Care Call Centers,

and peruse other materials located and linked at > www.telemedicinelawyer.com

2. Read >The Decade of Health Information Technology: Delivering Consumer-centric and Information-rich Health Care Framework for Strategic Action July 21, 2004
through at least page 32 and peruse the remaining portions of this document.

3. Read >NHII NHIN RFI materials for legal review purposes

4. Read >GAO July 2004 Report on NHII

5. Read >Federal Register: November 15, 2004 (Volume 69, Number 219) Page 65599-65601 in .html format
>Federal Register: November 15, 2004 (Volume 69, Number 219) Page 65599-65601 in .pdf format
>HHS NHIN FAQs Nov. 17, 2004 .html
>HHS NHIN FAQs Nov. 17, 2004 2004 .pdf

6. Read >Collaborative ONCHIT RFI Response
Collaborative Response submitted by: American Health Information Management Association (AHIMA), American Medical Informatics Association (AMIA), American National Standards Institute-Healthcare Informatics Standards Board (ANSI HISB), Center for Information Technology Leadership (CITL), Connecting for Health (CFH), eHealth Initiative (eHI), HIMSS EHR Vendor Association (EHRVA), Healthcare Information and Management Systems Society (HIMSS), Health Level Seven, Inc. (HL7), Integrating the Healthcare Enterprise (IHE), Internet2, Liberty Alliance, National Alliance for Health Information Technology (NAHIT)

For our class scheduled for February 16, 2005 at 6 PM, the assignment is as follows:

The ability to have a national health information infrastructure is challenged by issues raised, inter alia, in the
>GAO July 2004 Report on NHII
private/public interoperable e-health systems. Please consider each of the following in particular & refer to
>DOJ FTC Antitrust Guidelines for Collaborations Among Competitors - 2000 & >DOJ FTC Report - Health Care Antitrust - 2004 & other resources as appropriate:

1. Standard setting issues.
Interoperability inherently requires standard setting. When conducted by private parties, even with governmental promotion and participation, issues of procedural fairness and possible misuse of both the process and the substantive standards have lead to antitrust violations. See, e.g., Allied Tube etc v Indian Head, Inc., 486 U.S. 492 (1988).

2. Exemptions and immunities.
The extent and nature of government participation may create various exemptions and immunities for private parties participating under governmental supervision. See, e.g., Sessions Tank Liners, Inc. v Joor Mfg., 17F.3d 295 (9th Cir. 1994); (Noerr-Pennington doctrine and First Amendment immunity in standard setting context); Parker v Brown, 317 U.S. 341 (1943) (State action immunity.); National Gerimedical etc. v Blue Cross, 452 U.S. 378 (1981) (implied repeal.)

3. Joint venture issues.
Where private parties including competitors create a joint venture, even with governmental participation, they may encounter issues of market structure, collateral restraints, and spillover effects. See, e.g., Northwest Stationers v Pacific Stationery, 472 U.S. 284 (1985) (joint venture operating rules); and

4. What anti-trust issues are raised by so-called pay for performance and pay-for-use approaches?
See >FTC DOJ 1 and >FTC DOJ 2, and see also a recent >HHS OIG opinion of February 3, 2005 (No. 05-01) involving pay for performance.

For our class scheduled for February 23, 2005 at 6 PM, the assignment is as follows:

1. Each law student was assigned either topic 1, 2, 3, or 4 listed above in the February 16, 2005 assignment area. Your assignment for our February 23, 2005 class is to prepare a five to seven page memorandum of law (you may write a longer memorandum of law if you want to) regarding your assigned topic, analyzing the applicable law in the context of how the National Health Information Infrastructure initiative could best be implemented without being hindered, restrained, or otherwise adversely affected because of the federal antitrust legal issues raised in your topic listed above. We will discuss your memoranda during our class and each of you should be prepared to set forth a summary of your research and the basis for your conclusions and recommendations during our class. Please be sure to provide me with a copy of your memorandum of law Via Internet Email not later than 9 PM on February 22, 2005.

For our class scheduled for March 2, 2005 at 6 PM, the assignment is as follows:

1. Read >For the Record, published in 1997 by >Committee on Maintaining Privacy and Security in Health Care Applications of the National Information Infrastructure, Computer Science and Telecommunications Board, Commission on Physical Sciences, Mathematics, and Applications, and National Research Council
"This report investigates ways of protecting health information in an era of increasing computerization and far-reaching communications. It concentrates primarily on protecting patient-identifiable health information, that is, health records that contain information from which the patient's identity can be deduced or inferred.3 It assesses technical and organizational practices currently in use for protecting electronic health information, identifies other technologies worthy of testing in health care settings, and outlines areas for future research. In addition, the report discusses the privacy concerns that stem from the increasing exchanges of information among different types of organizations involved in providing care, paying for care, or conducting analyses of health information for a wide range of societal purposes. As the report notes, such sharing of information may pose greater privacy concerns than unauthorized access to health information stored at any individual location...." and comments of David Brailer, MD, Ph.D., National Coordinator for Health Information Technology, on February 17, 2005 in Dallas regarding NHII.

2. From time to time we will be using the >OCR HIPAA AdSi Web site, and the >CMS HIPAA AdSi Web site, so please become familiar with those Web sites now.

3. In subsequent classes, we will be referring to the >HIPAA Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996, and you should become familiar with this statute.

Note that HIPAA AdSi was amended by the >Administrative Simplification Compliance Act and the >Medicare Prescription Drug, Improvement and Modernization Act of 2003. More particularly, MMA added more "covered functions" and another HIPAA Administrative Simplification subtitle "covered entity" -- "a prescription drug card sponsor is a covered entity...."
"(h) QUALIFICATION OF PRESCRIPTION DRUG CARD SPONSORS AND ENDORSEMENT OF DISCOUNT CARD PROGRAMS; BENEFICIARY PROTECTIONS- `(1) PRESCRIPTION DRUG CARD SPONSOR AND QUALIFICATIONS- `(A) PRESCRIPTION DRUG CARD SPONSOR AND SPONSOR DEFINED- For purposes of this section, the terms `prescription drug card sponsor' and `sponsor' mean any nongovernmental entity that the Secretary determines to be appropriate to offer an endorsed discount card program under this section, which may include-- `(i) a pharmaceutical benefit management company; `(ii) a wholesale or retail pharmacy delivery system; `(iii) an insurer (including an insurer that offers medicare supplemental policies under section 1882); `(iv) an organization offering a plan under part C; or `(v) any combination of the entities described in clauses (i) through (iv)... (6) CONFIDENTIALITY OF ENROLLEE RECORDS- `(A) IN GENERAL- For purposes of the program under this section, the operations of an endorsed program are covered functions and a prescription drug card sponsor is a covered entity for purposes of applying part C of title XI and all regulatory provisions promulgated thereunder, including regulations (relating to privacy) adopted pursuant to the authority of the Secretary under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. 1320d-2 note). `(B) WAIVER AUTHORITY- In order to promote participation of sponsors in the program under this section, the Secretary may waive such relevant portions of regulations relating to privacy referred to in subparagraph (A), for such appropriate, limited period of time, as the Secretary specifies...."

Regarding our class scheduled for March 9, 2005:

We will discuss the reasons for and how you should proceed with respect to your second written memoranda assignment, as follows:
Review and analyze >http://www.medicare.gov/privacypractices.asp, wherein you will see the latest published version of the Notice of Privacy Practices under the HIPAA AdSi Privacy Rule by CMS, which is the largest HIPAA AdSi covered health plan. Analyze that version by annotating and determining and indicating (the WinWord changes feature would work well for that purpose but you can use some other technique if you would prefer) which portions of the final privacy rule each and every provision of this Notice of Privacy Practices appears intended to address and which requirements of the final privacy rule this Notice of Privacy Practices appears to be responding to, please. You should also prepare five to seven page (or more) memorandum to the Secretary of Health and Human Services commenting upon the Notice, from a legal perspective and also from a practical perspective: first, does the Notice appear to comply with the final privacy rule (is everything there that should be there in such detail as may be required (and, inter alia, is cross referencing FAQs adequate to respond to the privacy rule requirements or should all information be contained inside the Notice of Privacy Practices); second, if not, how could the Notice be enhanced and improved to assure likely compliance; and regardless of compliance, how might the Notice be improved to provide a better understanding of the privacy rule and an individual's rights under thereunder and under the Notice of Privacy Practices published by CMS; and third, as a part of one and two, compare and contrast the CMS version with other Notices of Privacy Practices and indicate how the CMS version either is deficient with respect to any of such others or is better and why.
See >http://www.umass.edu/uhs/ and click through to UHS H.I.P.A.A. Policy,
and
>http://www.metlife.com/Applications/Corporate/WPS/CDA/PageGenerator/0,1674,P3469,00.htm and
>http://www.med.umich.edu/hipaa/npp_official.htm Notices of Privacy Practices that you should use in your review comparison and analysis, please. You need not use all of these other Notices and, in fact, you should feel free to use others that you believe to be helpful if you so choose, so long as any others are available generally on the Web. In fact, you might want to use a Notice of Privacy Practices, amongst others, that you have received from a Covered Entity -- such as your physician, or a hospital you have visited; but again, only use same if available on the Web.
See >Readability of HIPAA Privacy Notices
and
>http://www.hrsa.gov/language.htm regarding readability and your consideration of the question whether the CMS Notice of Privacy Practices is readable sufficiently. Please refer to >http://www.hhs.gov/ocr/combinedregtext.pdf for the final privacy rule. In a addition, we will discuss portions of the final privacy rule specifically relating to covered entities, business associates, privacy policies and procedures, and business associate agreements.

Regarding our class scheduled for March 31, 2005:

Please read the following materials:

OCR Business Associate Agreement Sample Business Associate Agreement Security Rule Addendum Excerpts from preliminary hipaa ad si security rule 8 12 98 HCFA Internet Security Policy HIPAA AdSi Security statute mini-security rule health plan CMS Security 101 CMS Security Physical Safeguards Final Security Rule published in Federal Register

Your final assignment for this course of the three memoranda variety will be due not later than 9 PM on April 19, 2005 and I will post that assignment several weeks before that assignment is due. If you would like to substitute a twenty page plus paper in lieu of the three memoranda grading procedure, kindly advise me of your election not later than March 22, 2005.

Coming Attractions:

>Anti-Terrorism & Anti-MoneyLaundering Clause & >ASG materials for Open Source Software, & for Anti-Terrorism & Anti-Money Laundering & >Mozilla Public License

>ASG MMA Part D

Professional responsibility citations: Merrill Lynch & Co., Inc. v. Allegheny Energy, Inc., 2004 WL 2389822 (S.D.N.Y. Oct. 26, 2004) (holding no waiver of work product by giving outside auditor results of internal investigation) In re Pfizer, Inc. Securities Litigation, 1993 WL 561125 (S.D.N.Y.) In re Lupron Marketing and Sales Practices Litigation, 313 F.Supp.2d 8 (D. Mass 2004) (MDL class action following TAP Pharmaceutical litigation) United States v. Massachusetts Institute of Technology, 129 F.3d 681 (1st Cir. 1997) (required document disclosure to DCAA waived privileges that could be asserted against the IRS)

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