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Week Ending July 29, 2005
S.544 A bill to amend title IX of the Public Health Service Act to provide for the improvement of patient safety and to reduce the incidence of events that adversely effect patient safety.
BRIEF
Although explanations for the bill lean towards increasing patient safety it more so defines the creation of a database of patient information, how and by whom the information will be gathered and from whom, and defines the Patient Safety Organizations that will have a primary part in the plan the bill would implement.
Patient Safety Organizations (PSO) would be pubic or private and certified by the Sec. of Health and Human Services (HHS) to conduct efforts to improve patient safety and health care delivery. Those goals would be met by gathering and analyzing the collected patient data.
From there the bill shoulders up with a 2004 directive from the President to the Secretary of HHS to investigate and establish the viability of a nationwide, interoperable system of computers containing patient data. The selling point on that directive as is the case with this bill is the prediction that the records of a patient needing medical attention would be available instantly to help the attending doctor make the right treatment decisions and thereby reduce accidents and harm to patients from wrong diagnosis’, wrong prescriptions, non-obvious afflictions or allergies and so on. As such the Secretary is directed in this bill to establish and maintain a network of databases that can accept, aggregate and analyze patient data (The data would not be traceable to any particular patient) and develop voluntary standards to promote the electronic exchange of health care information. The information is protected from subpoena and other legal demands for discovery, however, criminal investigations seeking some information would be allowed access.
Participation for a while would be voluntary and cautions are taken to protect those who do provide the information from liability. State laws that protect patient data would be overridden by the bill and the information could not be subject to subpoena under any federal, state and local, civil or criminal law.
The patient information could come from, “a hospital, nursing facility, comprehensive outpatient rehabilitation facility, home health agency, hospice program, renal dialysis facility, ambulatory surgical center, pharmacy, physician or health care practitioner's office, long term care facility, behavior health residential treatment facility, clinical laboratory, or health center; or a physician, physician assistant, nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, certified nurse midwife, psychologist, certified social worker, registered dietitian or nutrition professional, physical or occupational therapist, pharmacist, or other individual health care practitioner; or any other individual or entity specified in regulations promulgated by the Secretary” the bill text read.
Sponsor: Senator James M. Jeffords (I-VT)
Vote: Passed Senate by Unanimous Consent (July 21, 2005) Passed House (RC 434) (July 26, 2005)
Cost to the taxpayers: CBO calculates the bill would cost “$5 million in 2006 and $58 million over the 2006-2010 period, assuming the appropriation of the necessary amounts. CBO estimates that receipts from fines for violation of the privacy protections, which are recorded as federal revenues, would amount to less than $500,000 a year.”
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MORE INFORMATION
`(c) Exceptions- Except as provided in subsection (g)(3)—
`(1) EXCEPTIONS FROM PRIVILEGE AND CONFIDENTIALITY- Subsections (a) and (b) shall not apply to (and shall not be construed to prohibit) one or more of the following disclosures:
`(A) Disclosure of relevant patient safety work product for use in a criminal proceeding, but only after a court makes an in camera determination that such patient safety work product contains evidence of a criminal act and that such patient safety work product is material to the proceeding and not reasonably available from any other source.
`(B) Disclosure of patient safety work product to the extent required to carry out subsection (f)(4)(A).
`(C) Disclosure of identifiable patient safety work product if authorized by each provider identified in such work product.
`(2) EXCEPTIONS FROM CONFIDENTIALITY- Subsection (b) shall not apply to (and shall not be construed to prohibit) one or more of the following disclosures:
`(A) Disclosure of patient safety work product to carry out patient safety activities.
`(B) Disclosure of non-identifiable patient safety work product.
`(C) Disclosure of patient safety work product to grantees, contractors, or other entities carrying out research, evaluation, or demonstration projects authorized, funded, certified, or otherwise sanctioned by rule or other means by the Secretary, for the purpose of conducting research to the extent that disclosure of protected health information would be allowed for such purpose under the HIPAA confidentiality regulations.
`(D) Disclosure by a provider to the Food and Drug Administration with respect to a product or activity regulated by the Food and Drug Administration.
`(E) Voluntary disclosure of patient safety work product by a provider to an accrediting body that accredits that provider.
`(F) Disclosures that the Secretary may determine, by rule or other means, are necessary for business operations and are consistent with the goals of this part.
`(G) Disclosure of patient safety work product to law enforcement authorities relating to the commission of a crime (or to an event reasonably believed to be a crime) if the person making the disclosure believes, reasonably under the circumstances, that the patient safety work product that is disclosed is necessary for criminal law enforcement purposes.
`(H) With respect to a person other than a patient safety organization, the disclosure of patient safety work product that does not include materials that--
`(i) assess the quality of care of an identifiable provider; or
`(ii) describe or pertain to one or more actions or failures to act by an identifiable provider.
`(3) EXCEPTION FROM PRIVILEGE- Subsection (a) shall not apply to (and shall not be construed to prohibit) voluntary disclosure of non-identifiable patient safety work product.
`(d) Continued Protection of Information After Disclosure-
`(1) IN GENERAL- Patient safety work product that is disclosed under subsection (c) shall continue to be privileged and confidential as provided for in subsections (a) and (b), and such disclosure shall not be treated as a waiver of privilege or confidentiality, and the privileged and confidential nature of such work product shall also apply to such work product in the possession or control of a person to whom such work product was disclosed.
`(2) EXCEPTION- Notwithstanding paragraph (1), and subject to paragraph (3)--
`(A) if patient safety work product is disclosed in a criminal proceeding, the confidentiality protections provided for in subsection (b) shall no longer apply to the work product so disclosed; and
`(B) if patient safety work product is disclosed as provided for in subsection (c)(2)(B) (relating to disclosure of non-identifiable patient safety work product), the privilege and confidentiality protections provided for in subsections (a) and (b) shall no longer apply to such work product.
`(3) CONSTRUCTION- Paragraph (2) shall not be construed as terminating or limiting the privilege or confidentiality protections provided for in subsection (a) or (b) with respect to patient safety work product other than the specific patient safety work product disclosed as provided for in subsection (c).
`
(4) LIMITATIONS ON ACTIONS-
`(A) PATIENT SAFETY ORGANIZATIONS-
`(i) IN GENERAL- A patient safety organization shall not be compelled to disclose information collected or developed under this part whether or not such information is patient safety work product unless such information is identified, is not patient safety work product, and is not reasonably available from another source.
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