S.Amdt. 1016

SA 1016. Mrs. CLINTON submitted an amendment intended to be proposed by her to the bill S. 1, to amend title XVIII of the Social Security Act to make improvements in the medicare program, to provide prescription drug coverage under the medicare program, and for other purposes; which was ordered to lie on the table; as follows:

On page 654, after line 18 and before the amendment to the title, insert the following:

SEC. ____. INFORMATION TECHNOLOGY.

(a) Improving Clinical Practices.--

(1) Telemedicine.--

(A) Licensing.--Section 1834(m)(4)(C)(i) (42 U.S.C. 1395m(m)(4)(C)(i)) is amended--

(i) in subclause (II), by striking “or” at the end;

(ii) in subclause (III), by striking the period and inserting “; or”; and

(iii) by adding at the end the following:

“(IV) in a State in which the respective State medical board has adopted a formal policy regarding licensing or certification requirements for providers at distant sites who do not have a license to practice medicine at the originating site.”.

(B) Expanding eligibility for reimbursement.--Section 1834(m)(4)(C)(i)(I) (42 U.S.C. 1395m(m)(4)(C)(i)(I)) is amended by striking “rural”.

(2) NIH trials to study impact of technology on cost and quality of health care.--

(A) Findings.--Congress makes the following findings:

(i) An estimated 80,000 to 100,000 patients die every year from errors suffered during hospitalization.

(ii) Many of these errors could have been avoided with changes to the system of health care delivery.

(iii) These systemwide changes have the potential to decrease the cost of providing health care and to increase the quality of services provided.

(iv) These improvements in cost and quality can be as dramatic as improvements seen with new technology or pharmaceutical advances.

(v) Currently new medical devices and medications undergo rigorous randomized controlled clinical trials to document their effect on a patient's health.

(vi) These clinical trials form the basis for providers to practice evidence-based medicine and to change their practices to improve their patients' outcomes.

(vii) Similar controlled clinical studies of systems-based approaches to changing practice, if available, can help providers implement systems-based measures to improve outcomes.

(B) Research on systems-based approaches to changing clinical practice.--Part B of title IV of the Public Health Service Act (42 U.S.C. 284 et seq.) is amended by adding at the end the following:

“SEC. 409J. RESEARCH ON SYSTEMS-BASED APPROACHES TO CHANGING CLINICAL PRACTICE.

“(a) Establishment.--The Secretary shall establish within the Office of the Director of NIH a Medical Systems Safety Initiative (referred to in this section as the ‘Initiative') to conduct and support research regarding systems-based approaches to improving and advancing medical care. The Initiative shall be headed by the Director of NIH (referred to in this section as the ‘Director').

“(b) Purpose.--The purpose of the Initiative is to enable the Director of NIH--

“(1) to conduct and support basic and applied research (including both intramural and extramural research), research training, the dissemination of health information, and other programs with respect to systems research, user-centered design, and human factors engineering within the National Institutes of Health to realize the expanding opportunities for improving health outcomes through the analysis and redesign of medical systems;

“(2) to enhance collaborative efforts among the Institutes to conduct and support multidisciplinary research in the areas that the Director determines to be most promising; and

“(3) to encourage and support clinical studies to provide scientifically and statistically rigorous and meaningful information about the utility and effectiveness of various systems-based interventions.

“(c) Appropriate Scientific Expertise and Coordination With Institutes and Federal Agencies.--The Director of NIH, after consultation with the Division of Research Grants, shall ensure that scientists with appropriate expertise in research on health systems, user-centered design, and human factors engineering are incorporated into the review, oversight, and management processes of all research projects and other activities funded by the Initiative. In carrying out this subsection, the Director, as necessary, may establish review groups with appropriate scientific expertise. The Director shall coordinate efforts with other Institutes and Federal agencies to ensure appropriate scientific input and management.

“(d) Ensuring High Quality, Rigorous Scientific Review.--In order to ensure high quality, rigorous scientific review with respect to the Initiative, the Director of NIH shall conduct or support the following activities:

(1) Outcomes research and investigations.

(2) Epidemiological studies on the incidence and prevalence of various systems, practices, and processes within the health care system and their effect on health outcomes, both beneficial and harmful.

(3) Health services research.

(4) Basic science research.

(5) Clinical trials.

(6) Other appropriate research and investigational activities.”.

(b) Improving and Promoting Electronic Medical Records.--

(1) Authentication standards.--The Director of the National Center for Vital and Health Statistics shall provide assistance to the Secretary of Health and Human Services in the development of authentication standards for health records. In developing such standards, the Secretary shall take into consideration the following:

(A) Recommendations for authentication technology and identification information standards that--

(i) provide for the reliable identification and retrieval of a patient's electronic medical data;

(ii) allow the patient to have detailed control over the access of individual components of his or her electronic medical record by being able to specify specific providers, each of whom will have access to limited portions of the electronic medical record;

(iii) minimize security risks, including the potential for--

(I) the patient to misrepresent his or her true identity;

(II) a health care provider to access data for which the patient has not consented to grant such access;

(III) a third party to access identification information; or

(IV) a third party to circumvent or exploit the authentication process in order to access electronic medical data without the consent of the patient;

(iv) allow for the timely and convenient creation of identification information at the time of contact between a patient and a provider, so as to minimize any disruption or delay in the provision of needed medical services to a patient who does not already have identification information; and

(v) maximize the probability of accurate identification, secure authentication, and rapid access to medical data even in situations where the patient--

(I) does not possess the identification information that is usually required for successful authentication, but wishes to grant consent to the provider to access necessary medical data;

(II) possesses the identification information but is not able to provide consent for the emergency access of medical data due to incapacitation; and

(III) is not able to provide identification information nor consent for emergency data access due to incapacitation.

(2) Personal health record.--

(A) Federal health information exchange standards initiative.--The Secretary of Health and Human Services, the Secretary of Defense, and the Secretary of Veterans' Affairs, in carrying out activities under the Federal e-Goverment Health Information Exchange Standards Initiative, shall jointly recommend standards for the implementation of personal health records that--

(i) includes the capability for patients to append to their electronic record information about--

(I) illnesses for which the patient did not seek professional medical care; and

(II) health information not related to a specific disease, episode, or illness; and

(ii) provides convenient access to the individual's full electronic medical record.

(B) Medical translation research.--

(i) In general.--The Director of the National Science Foundation shall award grants to public and nonprofit private entities for the conduct of basic research on innovative approaches to improve patients' understanding and comprehension of their electronic medical record. Research areas may include technology for the automated--

(I) translation of medical information to language more easily understandable by the patient;

(II) reorganization of the electronic medical record into a structure more useful to the patient; and

(III) integration of links to relevant information from other sources into the electronic medical record.

(ii) Merit review; competition.--Grants shall be awarded under this subparagraph on a merit-reviewed competitive basis.

(iii) Authorization of appropriations.--There are authorized to be appropriated to the National Science Foundation to carry out this subparagraph--

(I) $5,000,000 for fiscal year 2004;

(II) $10,000,000 for fiscal year 2005; and

(III) $15,000,000 for fiscal year 2006 and each fiscal year thereafter.

(3) Definitions.--In this subsection:

(A) Identification information.--The term “identification information” with respect to the medical records of a patient, means the data necessary to identify the patient.

(B) Authentication.--The term “authentication” means the process of using the identification information to validate the patient's identification and gain access to his or her electronic medical data.

(c) Improving Information Technology Infrastructure in the Basic Life Sciences.--Not later than 18 months after the date of enactment of this Act, the Director of the National Institute of General Medical Sciences shall submit to Congress a report on the activities of the Biomedical Information Science and Technology Initiative. Such report shall include--

(1) a description of current activities of the Biomedical Information Science and Technology Initiative Consortium;

(2) a summary of recently completed and ongoing grant programs; and

(3) recommendations for the further advancement of the Biomedical Information Science and Technology Initiative and bioinformatics and computational biology research in general.

(d) Improving Education and Training.--Subpart 3 of part D of title IV of the Public Health Service Act (42 U.S.C. 286c et seq.) is amended by adding at the end the following:

“SEC. 478B. CERTIFICATION OF INFORMATION WEBSITES.

“(a) In General.--The National Information Center on Health Services Research and Health Care Technology (in this section referred to as the ‘Center') shall develop a voluntary certification program for health information websites on the Internet. As part of such program, websites shall be deemed to be certified if they meet criteria that includes the following:

“(1) The website provides references to peer-reviewed rigorous scientific research for any conclusions or recommendations that it advocates.

“(2) The website is easy to navigate and comprehend by a general audience that does not have any specific medical training.

“(3) The website accommodates, to the maximum extent practicable, cultural, language, and literacy variation among its target audience.

“(b) Limitation.--In determining whether a website meets criteria for certification under the program under subsection (a), the Center may not consider--

“(1) the specific nature of the conclusions or recommendations of the website themselves, so long as they meet criteria for evidence as specified in subsection (a)(1); and

“(2) the person or organization responsible for the website.

“(c) Period Recertification.--In establishing the program under subsection (a), the Center shall develop a policy for the periodic expiration and renewal of certifications so as to ensure that websites are reviewed on a periodic basis for compliance with the criteria of certification.

“(d) Seal.--The Center shall develop a seal or marker that can be used by a website that is certified under the program under subsection (a) to indicate to its audience that the website has obtained the Center's certification.

“(e) Fee.--The Center may assess an application fee for websites in order to cover the costs of evaluating the website.”.