Recent Developments in Health Law

Health Insurance Portability and Accountability Act of 1996, Pub. L. No. 104-191 (codified at 42 U.S.C. $ 1320d (1996)).

45 C.F.R. §§ 160, 164 (2001).

45 C.F.R. §§ 160.102–103 (2001).

See HIPAAdvisory, What is HIPAA? A Basic HIPAA Primer, available at <http://www.hipaadvisory.com/regs/HIPAAPrimer1.htm> (last visited May 1, 2002).

Privacy of Healthcare Information Act, 1999 Haw. Rev. Stat. $ 323C (Supp. 2000) (repealed 2001).

Office of Information Practices, State of Hawaii, The Report of the Medical Privacy Task Force to the State of Hawaii 2001 Legislature, available at <http://www.state.hi.us/oip/medical_privacy_task_force_report.htm> (last visited May 1, 2002).

Gray M.T.D. Yale K. , “Privacy Lessons Learned from Hawaii: Delay, but Don't Put Off Compliance,” BNA Health Law Reporter, 11 (2001): 108.

1999 Haw. Rev. Stat. $ 323C–11.

1999 Haw. Rev. Stat. $ 323C–22.

1999 Haw. Rev. Stat. $ 323C–13.

1999 Haw. Rev. Stat. $ 323C–21.

1999 Haw. Rev. Stat. $ 323C–23.

See The Report of the Medical Privacy Task Force to the State of Hawaii 2001 Legislature, supra note 6.

1999 Haw. Rev. Stat. $ 323C–11.

See The Report of the Medical Privacy Task Force to the State of Hawaii 2001 Legislature, supra note 6.

See Id.

See Id.

See Altoon H. , “Medical Privacy Law Repeal Criticized,” Honolulu Star Bulletin (Apr. 29, 2001), available at <http://www.starbulletin.com/2001/04/29/news/story7.html>.

See Gray Yale , supra note 7, at 108.

Standards for Privacy of Individually Identifiable Health Information, 67 Fed. Reg. 14,776 (March 27, 2002).

See American Hospital Association, Eliminating Redundancy, available at <http://www.aha.org/hipaa/resources/news020325commentarypriv.asp> (last visited Apr. 5, 2002).

See Id.

See The Report of the Medical Privacy Task Force to the State of Hawaii 2001 Legislature, supra note 6.

See Gray Yale , supra note 7, at 108.

See Standards for Privacy of Individually Identifiable Health Information, 67 Fed. Reg. at 14,787.

See id. at 14,785.

See American Association of Medical Colleges, Letter to Secretary Thompson on Impact of Medical Privacy Rule on Research (Nov. 20, 2001), available at <http://www.aamc.org/advocacy/library/hipaa/corres/2001/081401.htm>.

See Standards for Privacy of Individually Identifiable Health Information, 67 Fed. Reg. at 14,776.

Prior to issuing the final rule, the California Department of Health Services will conduct a 45-day comment period on the proposed regulation in the spring of 2002. See Mahoney L. Gilroy T. , “California: California Rulemaking Would Set Nurse-to-Patient Ratios in Hospitals,” BNA Health Law Reporter, 11 (2002): 145.

Nurse-to-patient ratios explicitly mandate the number of patients cared for by a nurse at any one time. While ratio requirements are absolute, requests for waivers may be granted to rural general acute care hospitals. A.B. 394, 1999–2000 Sess. (Cal. 1999).

Department Proposed ratio.

Emergency rooms 1:4.

Medical-surgical 1:6.

Oncology 1:5.

Pediatrics 1:4.

Labor and delivery 1:2.

Post anesthesia 1:2.

ICU/CCU/neonatal intensive care 1:2.

Step-down units 1:4.

See California Nurses Association, New Era for Hospital Staffing: The Ratios are Here!!, available at <http://www.calnurse.org/cna/12202> (last visited May 1, 2002).

See A.B. 394, 1999–2000 Sess. (Cal. 1999).

See Tieman J. , “Counting Down: California Lawmakers Face Staffing Ratio Deadline,” Modern Healthcare, December 24, 2001, at 10.

See Mahoney Gilroy , supra note 1, at 145.

See Perera A. Morain D. , “Davis Pledges $60 Million to Train Nurses,” Los Angeles Times, January 24, 2002, at B–11.

See Mahoney Gilroy , supra note 1, at 145. DHS must adopt the regulations in accordance with licensing and certification regulations in §§ 70053.2, 70215, and 70217 of Title 22 and $ 1443.5 of Title 16 of the California Code of Regulations. A.B. 394, 1999–2000 Sess. (Cal. 1999).

See Tieman J. , “Absolute Minimum: California Announces Its Decision on Nurse-Staffing Ratios, and Other States Watch and Wait for the Ripples to Come Their Way,” Modern Healthcare, Jan. 28, 2002, at 8.

See California Nurses Association, supra note 2.

See Mahoney Gilroy , supra note 1, at 145.

See Tieman , supra note 8, at 8.

See Id.

See Mahoney Gilroy , supra note 1, at 145.

See Tieman , supra note 8, at 8.

See Tieman J. , “But Does It Work? Measuring Effect of Staffing Ratios Could Be Tough,” Modern Healthcare, March 4, 2002, at 10.

See California Nurses Association, Ratios to Halt RN Exodus, available at <http://www.calnurse.org/cna/12202/exodus.html> (last visited May 1, 2002).

See Mahoney Gilroy , supra note 1, at 145;.

Tieman J. , “Paying the Piper: California Hospitals Brace for Mandatory Compliance Costs,” Modern Healthcare, August 6, 2001, at 19.

See California Nurses Association, Frequently Asked Questions About California's New Ratios Law, available at <http://www.calnurse.org/cna/12202/faq2402.html> (last visited May 1, 2002).

See Tieman , supra note 15, at 10.

See, e.g., California Nurses Association, Attend a CE Class in Your Area: Class #A “Staffing Ratios: Implementation and Enforcement,” available at <http://www.calnurse.org/cna/pdf/ratce2002.pdf> (last visited May 1, 2002).

See Tieman , supra note 15, at 10.

See Tieman , supra note 8, at 8;

Schiff L. , “Staffing Ratios Proposed in California — But Still Not Final,” RN, 65 (2002): 14.

Tieman , supra note 17, at 19.

See Tieman , supra note 15, at 10.

See Id.

See Id.

N.X. v. Cabrini Medical Center, 97 N.Y.2d 247 (N.Y. 2002).

See Id.

See N.X. v. Cabrini Medical Ctr., 719 N.Y.S.2d 60, 61 (N.Y. App. Div. 2001).

See Id. at 61–62.

See Cabrini, 97 N.Y.2d at 250.

See Id.

See Cabrini, 719 N.Y.S.2d at 61.

Id. at 62.

See Id.

See Cabrini, 97 N.Y.2d at 250.

See Cabrini, 719 N.Y.S.2d at 62–63.

N.X. withdrew the charge of negligent hiring, however. See Id.

See Id. at 63–64.

Id. at 65.

Id.

See Id. at 70.

See Id. at 71–72.

See Id. at 71.

Id. at 75.

See Id. at 76.

See Cabrini, 97 N.Y.2d at 251.

See Id. at 252.

See Id. at 249.

See Id. at 252.

See Id. at 251.

See Id.

Judith M. v. Sisters of Charity Hospital, 93 N.Y.2d 932 (1999).

See id. at 933.

as cited in Cabrini, 97 N.Y.2d at 252.

See Cabrini, 97 N.Y.2d at 252.

Id.

See Cabrini, 719 N.Y.S.2d at 68.

See Cabrini, 97 N.Y.2d at 252.

See Id. at 255.

See Id. at 253.

See Id. at 254.

Id.

Stovall v. Confimed.com, 38 P.3d 707 (Kan. 2002).

Kan. Stat. Ann. $ 50–623 et seq. (2000).

See Stovall, 38 P.3d at 707.

See Id. at 709–10.

See Id. at 709.

Id.

See Id. at 709–10.

Id. at 710.

See Id.

See Id. at 709.

Id. at 710.

See Id.

Id. at 707.

One such example is as follows: “In determining whether an act or practice is unconscionable, the court shall consider circumstances of which the supplier knew or had reason to know, such as … the supplier made a misleading statement of opinion on which the consumer was likely to rely to the consumer's detriment.” Kan. Stat. Ann. $ 50–627(b)(6) (2000). The Supreme Court of Kansas found that there was nothing misleading about Dr. Levine's conduct, however.

See Stovall, 38 P.3d at 714.

Kan. Stat. Ann. $ 50–623 (2001).

See Stovall, 38 P.3d at 712.

See Id.

Id.

See Id.

See id. at 714.

quoting Willman v. Ewen, 634 P.2d 1061, 1064 (Kan. 1981).

See Id.

See Id.

See Id.

Id.

See Id. at 715.

See Raysman R. Brown P. , On-Line Advertising and Marketing, Technology Law, available at <http://www.brownraysman.com/publications/techlaw/nylj0999.htm> (last visited May 1, 2002).

J.E.M. AG Supply, Inc. v. Pioneer Hi-Bred International, Inc., 122 S. Ct. 593, 596 (2001).

35 U.S.C. §§ 161–164 (1994 ed. and Supp. V).

7 U.S.C. $ 2321 et seq.

J.E.M. AG Supply, 122 S. Ct. at 606.

Pioneer Hi-Bred Int'l, Inc. v. J.E.M. AG Supply, Inc., 49 U.S.P.Q.2d 1813 (N.D. Iowa 1998).

Pioneer Hi-Bred Int'l, Inc. v. J.E.M. AG Supply, Inc., 200 F.3d 1374 (Fed. Cir. 2000).

J.E.M. AG Supply, 122 S. Ct. at 606.

35 U.S.C. $ 101 (“Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement therefor, may obtain a patent therefor, subject to the conditions and requirements of this title.”).

See J.E.M. AG Supply, 122 S. Ct. at 597.

See Id.

See Id.

See Id.

In re Hibberd, 227 U.S.P.Q. (BNA) 443, 444 (1985).

See J.E.M. AG Supply, 122 S. Ct. at 594.

Diamond v. Chakrabarty, 447 U.S. 303 (1980).

J.E.M AG Supply, 122 S. Ct. at 598.

Id. “As Congress recognized, ‘the relevant distinction was not between living and inanimate things, but between products of nature, whether living or not, and human-made inventions.’”

Id. (quoting

Chakrabarty, 447 U.S. at 313).

See id. “As in Chakrabarty, we decline to narrow the reach of $ 101 where Congress has given us no indication that it intends this result.”

Id. at 606.

See Id. at 599.

Id. at 602.

Id. at 603.

Id. at 606.

“Stare decisis, however, prevents us from any longer regarding as an open question — as ambiguous — whether ‘composition of matter’ includes living things.”

Id. (citing

Chakrabarty, 447 U.S. at 312–13).

Id. at 607.

See Id. at 608.

See O'Connor K.W. , “Patenting Animals and Other Living Things,” Southern California Law Review, 65 (1991): 597–621, at 620 (arguing that intellectual property rights do not extend to the patenting of human beings because the Thirteenth Amendment of the U.S. Constitution bars such ownership interest).

See Hecht E.J. , “Beyond Animal Legal Defense Fund v. Quigg: The Controversy over Transgenic Animal Patents Continues,” The American University Law Review, 41 (1992): 1023–74 (discussing transgenic animal patents from an agricultural perspective).

See Id. at 1040.

See Id. at 1041.

See Id. at 1042.

See O'Connor , supra note 25, at 607 (stating the PTO decision in 1987 that it would grant utility patents for “non-naturally occurring nonhuman, multicellular living organisms, including animals”).

United States ex rel. Quirk v. Madonna Towers, Inc., 278 F.3d 765 (8th Cir. 2002).

31 U.S.C.A. §§ 3729–3733 (2002).

See Quirk, 278 F.3d at 766.

31 U.S.C.A. $ 3729 (2002) (Notes of Decisions, Section I, Part 4).

Damages are calculated as treble damages and civil penalties of $5,000 to $10,000 per false claim. 31 U.S.C.A. $ 3729(a) (2002). The qui tam plaintiff can receive up to 30 percent of the government's recovery. See Meyer J.A. Anthony S.E. , Reducing Health Care Fraud: An Assessment of the Impact of the False Claims Act (Washington, D.C.: New Directions for Policy for Taxpayers Against Fraud, 2001): at 9, available at <http://www.taf.org/publications/PDF/reducing.pdf>.

Quirk, 278 F.3d at 767 (citing Norbeck v. Basin Elec. Power Coop., 248 F.3d 781, 803 (8th Cir. 2001)).

See Id. at 766–67.

Id. at 767 (citing 42 U.S.C. $ 1395y(a)(2)).

Id.

See Id. at 769.

Id. at 767 (citing 31 U.S.C. $ 3729(b)).

Id. (citing 31 U.S.C. $ 3729(b)).

See id. at 768 (citing 31 U.S.C. $ 3729(b)(1)).

Id. (citing 31 U.S.C. $ 3729(b)(3)).

Id. (citing 31 U.S.C. $ 3729(b)(2)).

See Meyer Anthony , supra note 5, at 12.

See id. at 10, 17.

See 31 U.S.C. $ 3729(b). The 1986 amendments to the FCA “clarified the definition of ‘knowingly’ (the Act's requisite level of intent for liability).” Meyer and Anthony, supra note 5, at 10.

, M.A.K. v. Rush-Presbyterian-St. Luke's Medical Center, 764 N.E.2d. 1 (Ill. 2001).

M.A.K. v. Rush-Presbyterian-St. Luke's Med. Ctr., 736 N.E.2d 129 (Ill. App. Ct. 2000).

42 C.F.R. $ 1.01 (1993).

M.A.K., 764 N.E.2d at 10.

42 C.F.R. $ 2.31(a)(1) (2000) (implementing $ 543 of the Public Health Service Act, 42 U.S.C. $ 290dd-2 (1994)).

M.A.K., 764 N.E.2d at 3 (omissions of text in original).

See Id. at 3.

See M.A.K., 736 N.E.2d at 131.

See Id. at 132.

See Id. at 130.

20 Ill. Comp. Stat. Ann. $ 301/1-5 (West 1994).

See M.A.K., 764 N.E.2d at 4–5 (citing 42 U.S.C. $ 290dd-2 (1994)).

See id. at 5 (citing 42 U.S.C. $ 290dd-2(g) (1994)).

42 C.F.R. $ 2.31(a)(1) (2000) (“A written consent to a disclosure under these regulations must include: (1) The specific name or general designation of the program or person permitted to make the disclosure.”).

See M.A.K., 764 N.E.2d at 6 (citing Confidentiality of Alcohol and Drug Abuse Patient Records, 52 Fed. Reg. 21,796, 21,799 (June 9, 1987)).

M.A.K., 764 N.E.2d at 6.

See Id. at 6–7.

See Confidentiality of Alcohol and Drug Abuse Patient Records, 52 Fed. Reg. at 21,799.

M.A.K., 764 N.E.2d at 7.

See Id.

See id. at 14 (citing 42 C.F.R. $ 2.11 (2000)).

See Id. at 14–15.

See Id. at 17.

Id. at 16.