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April 2009 Archives

April 6, 2009

NY-Presbyterian to Offer PHRs

From today's New York Times online:

NewYork-Presbyterian Hospital, whose centers and clinics provide about 20 percent of the health care in New York, is the first large institution to move beyond the pilot stage this week as it begins to offer consumer-controlled health records for patients, and its experience will be closely watched in the industry.

NewYork-Presbyterian has been working with Microsoft for more than a year, not only on technical matters but also ease-of-use concerns with patients. The introduction will be gradual, beginning with heart patients, who will be told of the potential benefits of personal health records when they visit a NewYork-Presbyterian hospital or outpatient clinics.

See the rest here.

April 8, 2009

LI Hospitals Face Budget Shortfalls

From today's Newsday online:

Now that the state budget is passed, Long Island hospitals, two-thirds of which will lose a total of more than $40 million, are scrambling to figure out how to close their budget gaps.

"I think we're going to see program closures," said Kevin Dahill, president of the Nassau-Suffolk Hospital Council.

Read the rest here.

April 9, 2009

AERS: a useful tool for FDA

Excerpts from (FDA) CDER news 4/6/09. AERS, the Adverse Event Reporting System,contains over 4 million reports of adverse events and reflects data from 1969 to the present. Data from AERS are presented here (1) as summary statistics covering data received over the last 10 years. (updated 4/6/09)

Reports Received and Reports Entered into AERS by Year;
Domestic and Foreign Reports by Year;
Reporting by Healthcare Providers and Consumers by Year;
Patient Outcomes by Year. Serious outcomes include death, hospitalization, life-threatening, disability, congenital anomaly and/or other serious outcome.

The structure of AERS is in compliance with the international safety reporting guidance ICH E2B (2) issued by the International Conference on Harmonisation. Adverse events in AERS are coded to terms in the Medical Dictionary for Regulatory Activities terminology (MedDRA).
The # of domestic/foreign reports in AERS for 2008:
Domestic Foreign Unknown Total
287,028 149,033 5,316 441,367.
Not all of the reports that FDA receives for drug and therapeutic biologic products are entered into the AERS database. At the present time, they are entering reports of the following types:
-Reports submitted directly to FDA (not submitted through manufacturers);
-Reports submitted on 3500A (or CIOMS) forms by manufacturers that are categorized as: 15-day reports , serious Periodic reports, or nonserious Periodic reports for new molecular entity (NME) products within the first 3 years following FDA approval;
Reports submitted electronically by manufacturers regardless of category.
What is AERS Patient Outcomes data-see 21 CFR 310.305, 314.80, 314.98, 600.80 and Forms FDA 3500 and 3500A (the MedWatch forms).
AERS is a useful tool for FDA which uses it for activities such as looking for new safety concerns that might be related to a marketed product, evaluating a manufacturer's compliance to reporting regulations and responding to outside requests for information. The reports in AERS are evaluated by clinical reviewers in CDER and CBER to monitor the safety of products after they are approved by FDA. If a potential safety concern is identified in AERS, further evaluation might include epidemiological studies. Based on an evaluation of the potential safety concern, FDA may take regulatory action(s) to improve product safety and protect the public health, such as updating a product’s labeling information, restricting the use of the drug, communicating new safety information to the public, or, in rare cases, removing a product from the market.(3)

AERS data do have limitations.
-there is no certainty that the reported event was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event.
-FDA does not receive all adverse event reports that occur with a product. Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event. Therefore, AERS cannot be used to calculate the incidence of an adverse event in the U.S. population.

(1)http://www.fda.gov/cder/aers/statistics/default.htm
(2) http://www.ich.org/cache/compo/475-272-1.html#E2B http://www.fda.gov/cder/guidance/6675fnl.pdf latest Q’ and A’ FDA Guidance , including electronic reporting of AERs. The Implementation Working Group was discontinued 11/04, so all tech. q’s now addressed to Regional Regulatory authorities. http://www.ich.org/LOB/media/MEDIA1475.pdf document history
(3)http://www.fda.gov/cder/aers/default.htm

April 15, 2009

Design-Build Helps Cut Construction Costs

From today's New York Times online:

The first free-standing hospital project in New York State in more than two decades, according to the state's Department of Health, is being built in Middletown, using an unusual construction method to cut costs by almost a third.

To build what is estimated to be a $269 million hospital, Orange Regional Medical Center chose a construction company that uses the design-build method, which differs from traditional construction because the architect and general contractor are from one company.


Read the rest here.

April 22, 2009

Ricci v DeStefano before the US Supreme Court

From the SCOTUS blog (1), the [Supreme Court] will hear 70 minutes of argument in the consolidated cases of Ricci v. DeStefano (07-1428) and Ricci v. DeStefano (08-328), on the City of New Haven’s duty to promote white workers who scored highest on the firefighter civil service exam. While the legal reasoning on the issue (2) raised is the focus of today's news, the Brief for Industrial-Organizational Psychologists in Support of Respondent provides an interesting perspective. Below are some of the points made in the Brief:
Amici are experts in the field of industrial-organizational psychology and elected fellows of SIOP (Society for Industrial-Organizational Psychology), a Division of American Psychological Association, that is responsible for establishment of scientific findings and generally accepted professional practices in field of personal selection. (They have extensive experience in design/validations of promotional tests for emergency services departments, including fire and police across the country.) They argue that the City of New Haven...reasonable declined to certify the results of the 2003 New Hampshire Fire Department (NHFD) promotional exams for captain and lieutenant because validity of the tests could not have been substantiated under accepted scientific principles in the field of I/O.
Amici point out 4 serious flaws of these 2003 exams:
-their admitted failure to measure critical qualifications for the job of a fire company officer,
-the arbitrary , scientifically unsubstantiated weighting of the multiple-choice and oral components of the test battery,
-the lack of input from local subject matter experts regarding whether the tests matched content of jobs
-use of strict rank ordering without sufficient justification.
In sum, given the flaws in the NHFD exams which exacerbated the adverse impact on minority candidates, given the availability of proven alternative selection methods, the City had reasonably race neutral grounds for deciding against certifying the results of the flawed tests. Indeed, under Title VII of Civil Rights Act of 1964, it had no choice. Petitioners' attempt to turn a decision compelled by Title VII into a violation of Title VII on the basis of mere insinuations about the Boards supposed racial biases turns the statute on its head and should be rejected.
Amici state that proper validation of employment according to established standards is essential to ensuring a fair merit based selection, noting also that current I/O psychological research supports the use of promotional assessment centers as a valid and less discriminatory alternative to traditional testing methods.
(1)http://www.scotusblog.com/wp/
see also many other briefs filed on the merits.
(2)From SCOTUS WIKI:Whether municipalities may decline to certify results of an exam that would make disproportionately more white applicants eligible for promotion than minority applicants, due to fears that certifying the results would lead to charges of racial discrimination.

Continue reading "Ricci v DeStefano before the US Supreme Court" »

Maybe They Mean the Other HIPAA

In one of the more amusing misuses of HIPAA I've seen in 13 years, the Albany County Treasurer is claiming that she cannot release correspondence from individuals contesting parking tickets because of HIPAA. From today's Times Union:

The city treasurer has rejected lawmakers' request for copies of forgiven parking tickets, citing potential violations of federal protections of private medical records and the chilling effect disclosure could have.

. . . .

[Treasurer] Barnette's outside counsel, Brian Devane, was adamant that the council would not see those summonses without a "court order or legal authority." The attorney made good on that promise Monday, when council members received a letter rejecting the part of their request dealing with the dismissed tickets.

"Many times a written explanation accompanying the request that a ticket be adjudicated contains personal information provided by the applicant, sometimes including individual medical information and conditions," Devane wrote.

"Turning over such information to any third party would arguably violate the privacy rule of the Health Insurance Portability and Accountability Act of 1996 (HIPAA)."

Other than that it's hard to imagine circumstances under which a county treasurer would be either a covered entity or a business associate under HIPAA, I can't really think of much else to say.

Read the rest here.

About April 2009

This page contains all entries posted to HEALTH LAW SECTION BLOG in April 2009. They are listed from oldest to newest.

March 2009 is the previous archive.

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