Patient registry for mesothelioma data collection and research

Title III of the Public Health Service Act is amended by inserting after section 399V–6 of such Act (42 U.S.C. 280g–17) the following:

399V–7.

Patient registry for mesothelioma data collection and research

(a)

In general

The Secretary, acting through the Administrator of the Agency for Toxic Substances and Disease Registry, shall develop a patient registry to collect data on mesothelioma, including information with respect to the incidence and prevalence of the disease in the United States.(b)

Uses

The Secretary shall use the registry under subsection (a)—(1)to enhance and expand infrastructure and activities for tracking the epidemiology of mesothelioma patients;(2)to collect, consolidate, and report on health information on patients who have been diagnosed with mesothelioma, including with respect to—(A)treatment outcomes, including patient longevity; and(B)the number of patients receiving treatment for mesothelioma disaggregated by hospital;(3)to better describe the incidence and prevalence of mesothelioma in the United States;(4)to facilitate further research on mesothelioma;(5)to examine factors, such as environmental and occupational factors, that may be associated with mesothelioma;(6)to better outline key demographic factors (such as age, race or ethnicity, gender, and family history) associated with mesothelioma; and(7)to make the information in such registry, other than individually identifiable information, available to the public to facilitate and enhance research on, and prevention and treatment of, mesothelioma.(c)

Content

In carrying out this section, the Secretary—(1)shall provide for the collection and storage of information on the incidence and prevalence of mesothelioma in the United States;(2)when scientifically possible, shall provide for the collection and storage of other available information on mesothelioma, such as information concerning—(A)demographics and other information associated or possibly associated with mesothelioma, such as age, race, ethnicity, sex, geographic location, and family history;(B)risk factors associated or possibly associated with mesothelioma, including genetic and environmental risk factors; and(C)diagnosis and progression markers; and(3)may provide for the collection and storage of information relevant to analysis on mesothelioma, such as information concerning—(A)the epidemiology of the disease;(B)the natural history of the disease;(C)the prevention of the disease;(D)the detection, management, and treatment approaches for the disease; and(E)the development of outcomes measures.(d)

Consultation

In carrying out this section, the Secretary shall consult with individuals with appropriate expertise, including non-Federal mesothelioma experts including—(1)epidemiologists with experience in disease surveillance or registries;(2)representatives of national voluntary associations that focus on mesothelioma or have demonstrated experience in research, care, or patient service for mesothelioma;(3)health information technology experts or other information management specialists;(4)clinicians with expertise in mesothelioma; and(5)research scientists with experience conducting translational research or utilizing surveillance systems for scientific research purposes.(e)

Coordination with other Federal agencies

The Secretary shall make information in and analysis derived from the registry under this section available, as appropriate, to Federal departments and agencies, such as the National Institutes of Health, the Food and Drug Administration, the Centers for Medicare & Medicaid Services, the Agency for Healthcare Research and Quality, the Department of Veterans Affairs, and the Department of Defense.(f)

Public Access

Subject to subsection (g), the Secretary shall make information in, and analysis derived from, the registry under this section available, as appropriate, to the public, including researchers.(g)

Privacy

The Secretary shall ensure that privacy and security protections applicable to the registry under this section are at least as stringent as the privacy and security protections under HIPAA privacy and security law (as defined in section 3009).(h)

Reports to Congress

(1)

Initial report

Not later than 18 months after the date of enactment of the Mary Jo Lawyer Spano Mesothelioma Patient Registry Act of 2021, the Secretary shall submit to the Congress a report that—(A)shall outline—(i)the findings in the mesothelioma patient registry under subsection (a);(ii)future plans for expansion or revision of such registry; and(iii)the scope of such registry; and(B)may include a description of the activities undertaken by the Secretary to establish partnerships with research and patient advocacy communities to expand such registry.(2)

Subsequent report

Not later than 4 years after the date of enactment of the Mary Jo Lawyer Spano Mesothelioma Patient Registry Act of 2021, the Secretary shall submit a report to the Congress concerning the implementation of this section. Such report should include information on—(A)the development and maintenance of the mesothelioma patient registry under subsection (a);(B)the type of information collected and stored in the registry;(C)the use and availability of such information, including guidelines for such use; and(D)the use and coordination of databases that collect or maintain information on mesothelioma.