Information disclosure, standard

The government should strengthen the standardization, institutionahzation, legalization of the information disclosure in the especially serious accident. Meanwhile, the government should standardize the job behaviors of the spokesman, the content and procedure of the information disclosure, and estabhsh the accountabihty system in the information disclosure. 

The latter view prevailed but generated yet another set of issues as to whether disclosure rules should be evaluated from the perspective of professionals or patients. Some courts took the narrower view of duty by ruling that professional standards should be used to determine what should be disclosed to patients. Although this theory of "lack of informed consent" was distinct from whether the health care provider had violated the standard of care, most courts, and many legislatures, confined the doctrine s operation to a very narrow set of circumstances consistent with the negligence standard underlying the standard of care in medical cases. Other courts took what is called the broader view and leaned toward the patient s perspective while requiring juries to impose the reasonable patient s view of risk rather than the particular patient s view of risks. 

I mentioned three factors in federal law which impact on this disclosure problem. The first is that the Freedom of Information Act makes it difficult to withhold information. It does this both by an uncertain standard of confidentiality, and by the omission of the procedural protection which comes with all other kinds of adjudicative decisions by federal agencies. The courts rewrote the Freedom of Information Act s original intent in the 1974 National Parks v. Morton decision. Since that time, each submission to an agency has been vulnerable to disclosure if the owner fails to carry a rather difficult burden of proof That disclosure would cause substantial harm to competitive position at the time the disclosure is made. Assume that the owner of a secret catalyst had a market share of 10 in specialty fatty acids for rubber production, and filed the catalyst information with the EPA on April 1, 1982. When the request for disclosure comes in November 1983, what will the firm s market position be then, and how much would this... 

This chapter will focus on some, but not all, of the areas in which the U.S. Food and Drug Administration (FDA) and the European Union (EU) regulatory authorities have attempted to coordinate their efforts to provide uniform rules and standards for the pharmaceutical industry. Specifically, we will review the efforts to harmonize approaches relating to inspections (including public disclosure of confidential information) and product approval or authorization (including clinical trials). While space limitations do not provide sufficient opportunity to describe each regulatory authority s system or the harmonization attempts in detail, it is our hope to provide some background of where the efforts are now, where the efforts are intended to go, and what we believe will be the results of these efforts. In addition, the author is much more familiar with the U.S. system than the EU system because of his experience and daily exposure with FDA, this chapter will focus more on the U.S. structure. 

The first court decisions applied the same legal test to informed consent cases that was applied to negligence cases The practitioner was held to the standard of the reasonable person. Liability was imposed if the practitioner was found to have breached the duty to act as a reasonable practitioner would have acted under the same or similar circumstances. In determining the standard of care expected of the practitioner, the courts allowed other practitioners to testify concerning the warnings or disclosures that were necessary. Hence, the standard was a profession-set one, based on expert testimony and determined by the conduct of other practitioners. If the defendant practitioner provided that amount of information deemed to be reasonable by other practitioners, then a breach of duty did not occur. 

In the United States, federal legislation called the Health Insurance Portability and Accountability Act of 1996 (HIPAA) to make patient information more strictly protected than before. Although most pharmaceutical companies have limited access to patient names and other health information, any patient information must be carefully guarded to avoid violation of HIPAA statutes, which address the use and disclosure of individuals medical information by covered entities , and set standards for individuals rights to control the use of their medical information. Violations can result in fines and/ or, in some instances, imprisonment. 

HIPAA is the acronym for the Health Insurance Portability and Accountability Act of 1996. HIPAA evolved as a result of the rapid evolution of health information systems technology as well as the challenges for maintaining the confidentiality of health information. HIPAA was introduced initially as the Kennedy-Kassebaum bill, an outgrowth of the Clinton administration s attempt to revamp the health care system. The result in HIPAA was an effort to streamline and standardize the health care system and to establish the privacy of subject information. The result of this effort was the issuance of the final HIPAA rules in August, 2002, which establish the requirements that prevent the disclosure of individually identifiable health information (Privacy Rule) (1) without authorization from the subject. An accidental posting of individuals health records and fraudulent use of medical records precipitated the passage of HIPAA. 

As noted above, FOIA Exemption 4 protects not only trade secrets but also confidential commercial and financial information. Commercial or financial information is confidential if its disclosure is likely. .. to cause substeintial harm to the competitive position of the person from whom the information was obtained. National Parks and Conservation Association v. Morton, 498 F.2d 765, 770 (D.C. Cir. 1974) (National Parks I) (emphasis added). This test does not require that harm be proven with mathematical precision. Rather, it looks generally to the commercial sensitivity of the information. For example, in National Parks and Conservation Association v. Kleppe, 547 F.2d 637, 683 (D.C. Cir. 1976) (National Parks II), the United States Court of Appeals for the District of Columbia stressed that a court (or agency) need only exercise its judgment in view of the nature of the material sought and the competitive circumstances in which the [information submitters] do business. . . . Under this standard, virtually any information could qualify for nondisclosure providing its competitive sensitivity could be adequately documented. 

EPA could require information on warning labels where there is evidence that the chemicals in question present an unreasonable risk and disclosure of confidential information is necessary to protect against that risk. It should be noted, however, that this provision imposes a high standard on EPA. The Agency must show not merely that a chemical poses an unreasonable risk but that the inclusion of confidential information in warning labels represents the only effective mechanism for controlling that risk and other approaches are inadequate. EPA probably could not meet this standard where users of a chemical would be adequately informed about potential risks by a generic description of the chemical s identity or where a description of the hazard posed by the chemical and appropriate precautionary instructions are adequate to assure its safe use. 

Recent patent disclosures by the Standard Oil Co. of Indiana indicate that their process for the polymerization of ethylene is also a relatively low-pressure process, and the following process information is based on these disclosures. The polymerization process is a fixed-bed process employing a prereduced catalyst, ethylene pressures of 809-1,000 psi, and temperatures somewhat greater than 200°C. The metal oxides (such as nickel, cobalt, and molybdenum) can be supported on either charcoal or alumina, and materials such as lithium aluminum hydride, boron, alkali metals, and alkaline-earth hydrides may be used as promotors. Variations of this process are reported to produce polyethylene resins with densities from 0.94-0.97. 

Safety professionals shonld be aware that the company or organization wonld be reqnired to make reasonable accommodations for any/all known physical or mental limitations of the qnalihed individnal with a disability, unless the employer can demonstrate that the accommodations wonld impose an undue hardship on the business, or that the particnlar disability directly affects the safety and health of that individnal or others. Safety professionals should also be aware that included under this section is the prohibition against the use of qualihcation standards, employment tests, and other selection criteria that can be used to screen out individuals with disabilities, unless the employer can demonstrate that the procedure is directly related to the job funetion. In addition to the modifications to facilities, work schedules, equipment, and training programs, the company or organization is required to initiate an informal interactive (communication) process with the qualified individual to promote voluntary disclosure of his or her specific limitations and restrictions to enable the employer to make appropriate accommodations that will compensate for the limitation. ... 

Trade Secrets. Requirements exist that are similar to trade secret provisions of the 1910.1200 Hazard Communication standard requiring information required by the PSM standard to be available to employees (and employees representatives). Employers may enter into confidentiality agreements with employees to prevent disclosure of trade secrets. 

Standards can have a restrictive effect on new materials as well. The FDA now requires that if a company cites a standard in its premarket notification, a Form 3654 must be completed, which is intended to detail to the Agency the extent to which the standard was applied. The form can be a grueling exercise if not considered at the beginning of letting the contract for testing or if the impact it may have on the submission is not properly understood. The form must include details of any adaptation of the standard to the device under review, deviations from the standards, requirements not applicable to the device, and the name and address of the test laboratory or certification body involved in assessment of conformance to this standard. If this information is not present in the laboratory report, the applicant must provide the information as an attachment to the form for each standard cited. For many standards, completing this form has become an onerous task. Unfortunately, without this level of disclosure, it can be difficult for the FDA to understand the degree to which the biotextile conforms to the claimed standard. Because such standards citations can become product claims of performance, such detailed information is necessary. 

The proposed legislation would provide for disclosure of basic safety information for all chemicals in use and the reduction or phasing out of the most dangerous chemicals. It would also establish a standard for assessing chemical safety that accounts for real-world exposures. 

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