Tuesday, April 26, 2011

Who Can Disclose or Sell Info Gathered to Fulfill a Government Regulation? Prescriber-Identifiable Data and the Case of Sorrell will Give Us Information about Supreme Court Justices' View of the Law

See the update
to this posting
Outcome in Sorrell v. IMS Health Fairly Clear After SCOTUS Oral Argument

Given the oral argument on this case, our commentary below is moot.

U.S. Supreme Court
Oral Argument, April 26, 2011 (upcoming today)

This is such a simple case that it will demonstrate quite clearly how the various Supreme Court factions understand "the law" (or "if" they understand the law).

The primary question -- for us -- is already the question of the question.

FIRST, we would ask: What are a patient's rights to his or her personal medical data? For us, that already decides the case. The PATIENT must consent to use of his or her medical data as desired. Otherwise, there is violation of privacy.

SECOND, we would ask: What are a physician's rights to the personal medical data of his patients? For us, that already decides the case. The PATIENT must consent to a physician's use of his or her medical data as desired. Otherwise, there is a violation of privacy and a breach of a confidential relationship.

THIRD, we would ask: What are a pharmacist's rights to the personal medical data of a physician's patients insofar as this is obtained via prescriptions that are filled, recorded and maintained in order to fulfill government regulations? The PATIENT must consent to a physician's use of his or her medical data as desired and the PHYSICIAN must consent to a pharmacist's use of the physician's records regarding that patient.

FOURTH, and beyond that, we would then define the subsequent question broadly as follows: can any non-governmental entity without consent of the affected party disclose or commercially sell or otherwise exploit identifiable personal information about that party which has come into its hands solely because of its fulfillment of a governmental regulation without which the disclosure and sale of such data without consent would otherwise be illegal?

FIFTH, an ancillary question here would also be whether the level of identifiable detail of information sold is relevant. For example, the U.S. government sells Bureau of Census information which has been generalized and does not reveal detailed identifiable personal information about anyone. In the instant case, it is in fact the prescriber-identifiable detail of the information which is of greatest value to the pharmaceutical buyer of privileged personal medical data.


To our astonishment, the legal battle as it has been submitted to the Supreme Court frames the question of law quite differently, in what must be the most bizarre "understanding" of free speech that we have ever seen.

DECISION BELOW: 2010 WL 4723183  
LOWER COURT CASE NUMBER: 09-1913-cv, 09-2056-cv

Prescription drug records, which contain information about patients, doctors, and medical treatment, exist because of federal and state regulation in this highly regulated field. This case is about information from prescription records known as "prescriber-identifiable data." Such data identifies the doctor or other prescriber, links the doctor to a particular prescription, and reveals other details about that prescription. Pharmacies sell this information to data mining companies, and the data miners aggregate and package the data for use as a marketing tool by pharmaceutical manufacturers. The law at issue in this case, Vermont's Prescription Confidentiality Law, affords prescribers the right to consent before information linking them to prescriptions for particular drugs can be sold or used for marketing. The Second Circuit held that Vermont's law violates the First Amendment, a holding that conflicts with two recent decisions of the First Circuit upholding similar laws. The question presented is: Whether a law that restricts access to information in nonpublic prescription drug records and affords prescribers the right to consent before their identifying information in prescription drug records is sold or used in marketing runs afoul of the First Amendment.

CERT. GRANTED 1/7/2011"
That the PATIENT'S rights of privacy are being violated is not even mentioned. Incredible.

His or her personal medical data are apparently seen as "legally appropriated" either by his or her physician, pharmacist or drug company, to do with as they please.

In the instant case, it is presumed by one party that the PHYSICIAN owns the patient's medical records and history and can dispense with them as he pleases, depending only on whether the physician consents to the pharmacist's sale of the records to drug companies or not. The patient has no say in the matter.

The opposing side presumes that both the patient and physician have given up their rights to the data once the pharmacist fulfills a prescription and that now the PHARMACIST can do with the PATIENT'S medical data what he or she wishes, including selling that data to the highest bidder.

Really, sometimes one has the impression that law in America has totally failed.

We would find that ANY use of a patient's medical data beyond diagnosis and treatment by the physician -- who is sworn to protection of the confidential relationship that exists between them, similar to the physician-patient privilege -- is a violation of the patient's rights.

FIRST, the patient has to give his consent.
SECOND, the physician has to give his consent.
THIRD, the pharmacist has to give his consent -- and that has been denied as a possibility by the Vermont law if the physician says no.
Only if the physician says yes -- and only if the patient says yes - should otherwise personally privileged identifiable medical data be given to anyone.

So, we are watching this case with great interest to see how or if it separates the wheat from the chaff in the persons on the bench of the U.S. Supreme Court.

A Guide to Doing Business in Germany by the U.S. Department of Commerce via the Embassy Staff in Germany

Thinking of doing business in Germany?

Take a look at the BuyUSA.gov website
which presents
Doing Business in Germany
a U.S. Commercial Service of the U.S. Department of Commerce
via material prepared by the U.S. Embassy staff in Germany.

Law, WWF, Sport Hunting, Polar Bears, Endangered Species Act, Illegal Imports of Animal Trophies: plus, the Conservation Protection Situation in Germany

Erika Bolstad at the McClatchy Newspapers writes in Hunters' polar-bear trophies stuck in legal limbo about the effect of the Endangered Species Act on the sport hunting of polar bears in the northern regions of the world and the illegality of importing polar bear trophies into the USA, even if hunted prior to the Act:
"The Endangered Species Act prohibits importing animals that are listed as endangered or threatened. As a result, sport-hunted polar bear trophies from Canada can't be imported, the government argues, even if they were hunted before the bears were considered threatened."
It is estimated that there are about 25,000 polar bears left in a range across Canada, Russia, Greenland, Norway and Alaska, where local provinces also have their own rules about permissible hunting ("harvest rules"). For example, even U.S. law still permits Alaska Natives to shoot about three dozen polar bears each year. According to Bolstad, quoting polar bear expert Geoff York, The World Wildlife Fund, for example, does not oppose "sustainable harvests when they benefit local economies".

The tradition of hunting game for survival is as surely as old as the history of mankind so that it is difficult to oppose polar bear sport hunting on "strictly moral" grounds. Man's killing of animals for his own purposes is widespread on our planet. As one commenter to the article noted in replying to sport hunting critics:

"I don't know where you think your leather shoes, belts and double cheeseburgers come from...."

The opponents of course argue understandably that killing for sport rather than necessity are two horses of a different color, but there is a fine line there somewhere. That line raises the question of how many polar bears any geographic area can tolerate before they become dangerous or economically harmful and how much "sustainable harvesting" is required to keep animal populations healthy, regardless of the motivations of the individual hunters.

Here in Germany, for example, annual hunts of wild boar and deer and other animals are necessary in order to reduce overpopulation, which if uncontrolled results, for example, in wild boars literally invading human-inhabited locations and leaving a trail of destruction.

Moreover, wild boar and deer on German roads contribute heavily to thousands of accidents each year, with many human injuries, including fatalities, which has led many autobahns to be "fenced off" and special overpasses just for animals to be constructed at great cost in order not to bar animals from their natural territory. See e.g. Verkehrsrundschau.de.

The "sustainable harvest" of animals by hunting is in fact necessary and regularly practiced in Germany and we take the following figures from the Deutsche Jagd Zeitung djz.de for the year 2007/2008 as an example: harvested were 447,000 boar, 1 million deer (yes, Germany has many deer and forests), 525,00 rabbits, 269,000 wild hares, 543,000 foxes, 29,000 racoons, and 26,700 racoon dogs. It is always amazing to this observer that a country so thickly populated by humanity as Germany still has such a massive population of wildlife. In this connection, the forestry profession is quite important and the local forester is a respected person.

Living in an intelligent harmony with plants and wildlife is essential, as shown above. In Germany the Federal Agency for Nature Conservation (Bundesamt für Naturschutz, BfN) publishes national Red Lists of endangered species which are supplanted by local state published lists as well.

The German protection of nature is detailed in English at WISIA Online, which points to the German Federal Nature Conservation Act (Bundesnaturschutzgesetz, BNatSchG) and the German Federal Ordinance on the Conservation of Species ((Verordnung zum Schutz wild lebender Tier- und Pflanzenarten, Bundesartenschutzverordnung, BArtSchV), as well as to the Federal Hunting Act (Bundesjagdgesetz, BJagdG) and the Federal Game Conservation Ordinance (Bundeswildschutzverordnung, BWildSchV).

Article 1 of the Bundesartenschutzverordnung (Bundesartenschutzverordnung - BArtSchV) provides a list of protected species, as these are protected in Germany by a variety of measures (e.g. "hunting bans, raptor nest surveillance, bat nesting boxes, amphibian tunnels, etc." ).

There are special restrictions imposed via the Foreign Trade Act (Außenwirtschaftsgesetz, AWG) the export list (Ausfuhrliste) and import list (Einfuhrliste) in the broader sense that protected animals and plants and their products can not be imported or exported pursuant to CITES (Convention on International Trade in Endangered Species of Wild Fauna and Flora, Washington Convention ()).

Protected animals can not be sold in Germany, also not on websites such as eBay, and violators can be imprisoned.

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