A bill to establish programs that use the Internet to provide to patients and health care practitioners coordinated information on diseases and other conditions, and for other purposes

2008·0.71 MB·English

by  United States. Congress. House

I
110thcongress H.R.7199
2dSession
To establish programs that use the Internet to provide to patients and
healthcarepractitionerscoordinated informationon diseasesand other
conditions,andforotherpurposes.
IN THE HOUSE OF REPRESENTATR^S
September28,2008
Mr.Cannonintroducedthefollowinfjbill;whichwasreferredtothe
CommitteeonEnergyandCommerce
A
BILL
To establish programs that use the Internet to pro\ide to
patients and health care practitioners coordinated infor-
mation on diseases and other conditions, and for other
purposes.
1 BeitenactedbytheSenateandHouseofRepresenta-
2 tivesoftheUnitedStatesofAmericainCongressassembled,
3 SECTION1.SHORTTITLE.
4 ThisAct maybe cited as the "Mechcal Information
5 andTreatmentAccessAct".
6 SEC.2.TABLEOFCONTENTS.
7 ThetableofcontentsforthisActisasfollows:
Sec. 1. Shorttitle.
Sec.2. Tableofcontents.
2
Sec. 3. Findings.
TITLE I—FEDERAL INTERNET SITE FOR CONSOLIDATION AND
TRANSLATION OF INFORIVIATION ON DISEASES AND OTHER
CONDITIONS
Sec. 101.Internetsite.
TITLEII—ADDITIONALFORUMSFOREXCHANGEOFHEALTH
INFORMATION
Sec. 201.Fonimregardingoff-labelusesofnewdrugsanddevices.
See. 202.JohnEisenbergforumregardingsurgicalprocedures.
See. 203.JohnEisenbergforumregardingcomplementaiyandalternativemed-
icine;dietarysupplementsandfood.
TITLEIII—GENERALPROVISIONS
Sec. 301.Definitions.
See. 302.Effectivedates.
1 SEC.3.FINDINGS.
2 TheCong:ressfindsasfollows:
3 (1) The Congfress andtheAmerican people de-
4 sire to live healthy hves and foster an effective and
5 efficient health care system. This system requires
6 timely, accurate, and ever-iinpro\inginformation re-
7 sources. Tliiswillfostermaximization ofhealthcare
8 outcomes andhelp health carepractitioners andpa-
9 tientspartnerformoreeffectiveresults.
10 (2) TheInternetisauniquetoolofferingaccess
11 to great volumes of information. Some is accurate
12 and some isnot. Therehas alsobeen extensive gov-
13 ernment investment in placing medical information
14 ontheInternetinmanydiverseplaces.
15 (3) Thereisaneedtoconsohdateandtranslate
16 this mjTiad of information for physicians and con-
17 sumers, fromthelistingofclinical trials to the pro-
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1 tocols for treatment ofvarious diseases and eondi-
2 tions, as well as the integration of new discoveries
3 and the evaluations ofoutcomes-based examinations
4 ofdrugs andde^'icesforconditions otherthanthose
5 for wliich they are already approved. This Avill lead
6 to more accurate treatment, fewer medical errors,
7 and more successful outcomes, while also protecting
8 patients, a physician's right to practice medicine,
9 and a patient's right to access the health care the
10 patientdesires.
11 (4) The Food and Drug Administration is
12 vTuiquely qualified to assist the Nation in fulfilling
13 this mission to improve health care for the benefit
14 of Americans. The Administration already coordi-
15 nates the information needs of many government
16 agencies and equivalent regulators' bodies in other
17 countries.
18 (5) In pro\iding Internet-based forums for ob-
19 taininganddisseminatinghealth-relatedinformation
20 (including information on surgical procedures; com-
21 plimentaryand alternative medicine; dietar}^ supple-
22 ments and food; and unapproved treatments), the
23 Food and DrugAdministration should work closely
24 with educational institutions, schools of medicine,
25 and other appropriate private entities and ensure
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1 that the expertise of such entities is appropriately
2 utihzed.
TITLE I—FEDERAL INTERNET
3
SITE FOR CONSOLIDATION
4
AND TRANSLATION OF INFOR-
5
MATION ON DISEASES AND
6
OTHER CONDITIONS
7
8 SEC.101.INTERNETSITE.
—
9 (a) In General. The Secretary of Health and
10 Human Sendees, acting through the Commissioner of
11 FoodandDrugs,shallcarrj^outaprogramwhosemission
12 is, through an Internet site maintained for purposes of
13 theprogram
14 (1) to consolidate and translate health care in-
15 formation that is available to the public from Fed-
16 eral agencies, linking the various health-related
17 Internetsitesofsuchagencies;and
18 (2) toassistinthetranslation andreportingof
19 diseaseorcondition protocols forphysicians and lay
20 persons.
21 (b)InformationonDise^isesandOtherCondi-
—
22 TIONS. TheSecretaryshaUensurethattheInternetsite
23 undersubsection (a) has capacitiesthatenable auserof
24 the site to enter the name of a disease or other health
25 condition and obtain Internethnks appropriatetohealth
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1 carepro\iders, andlinksappropriatetolaypersons, that
2 provide
3 (1) an exjolanation ofthe health condition; and
4 (2) information on all available treatment pro-
5 toeols,including'
6 (A) standard medical practice protocols;
7 and
8 (B) any clinical trials, and any outcomes-
9 basedtreatmentprotocols,that
10 (i) are being conducted or supported
11 bytheNationalInstitutesofHealth;
12 (u) are included in the registry and
13 results data bank under section 402(j) of
14 the Pubhc Health Ser\dce Act (42 U.S.C.
15 282(j));
16 (iii) are being conducted pursuant to
17 theFederalFood, Drug, andCosmeticAct
18 orsection351 ofthePublicHealthSendee
19 Act;
20 (iv) are being conducted pursuant to
21 section201 ofthisAct;or
22 (v) are identified pursuant to section
23 201 or202 oftliisActorpursuantto sec-
24 tion 485D(i) ofthe Public Health Service
25 Act (as addedbysection 203 oftliisAct).
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1 (e) Federal Databases. Internet links under
2 subsection(b)shallincludethefollowing:
3 (1) Links that pro\ide information on how to
4 enroU in a chnical trial referred to in subsection
5 (b)(2)(B) andhowtobetreatedunderanoutcomes-
6 based treatment protocol referred to in such sub-
7 section.
8 (2) Links to Federal electronic databases that
9 are available to the public and provide disease-spe-
10 cificorcondition-specificinformation, includingsuch
11 databases of the National Institutes of Health, the
12 CentersforDiseaseControlandPrevention, andthe
13 FoodandDrugAdministration.
14 (3) A hnk to the Internet site under section
15 204(a) (relatingto research and treatments carried
16 outpursuantto section 201, andtheidentityofthe
17 healthcarepractitionersinvolved).
18 (4) A link to the Internet sites under sections
19 201 and202 ofthisActandtheInternet siteunder
20 section485D(i) ofthePublicHealthSendeeAct(as
21 addedbysection203oftliisAct).
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22 (d)DateCertainforOperationofProgram.
23 TheInternetsiteundersubsection(a)shallbeestabhslied
24 andreadyforusebyhealthcarepractitionersandlayper-
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1 sonsnotlaterthantwoyearsafterthedateoftheenact-
2 mentofthisAct.
TITLE II—ADDITIONAL FORUMS
3
FOR EXCHANGE OF HEALTH
4
INFORMATION
5
6 SEC. 201. FORUM REGARDING OFFLABEL USES OF NEW
7 DRUGSANDDEVICES.
—
8 (a)InGeneral. TheSecretary,actingthroughthe
9 Commissioner of Food and Drugs, shall (directly or
10 through contract) estabhsli a program under wliicli the
11 folloA\ingoccur:
12 (1) HealthcarepractitionerssubmittotheSec-
13 retarv' information obtained in the course of their
14 professionalpracticesregardingoff-labelusesofnew
15 drugsanddevices.
16 (2) TheSecretarymaintainstheinformationre-
17 ceivedunderparagraph (1); makes suchinformation
18 availabletohealthcarepractitionersandthegeneral
19 public through one or more Internet sites; and re-
20 ceives, maintains, and makes availablethrough such
21 site appropriate conunents andinformationprovided
22 inresponsetosuchinformation.
23 (3) The Secretarycarries outparagraph (2) in
24 a mamier reasonably calculated to pro\dde a forum
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1 forobtaininganddisseminatinginformation, includ-
2 ingclinicaldata,towardthefollowinggoals:
3 (A) IdentiMngoff-labeluses ofnewdrugs
4 and devices that are reasonable candidates for
5 approval under section 505 or 515 ofthe Fed-
6 eral Food, Drug, and Cosmetic Act or under
7 section351ofthePubheHealthServiceAct.
8 (B) Identifyingoff-labeluses ofnewdrugs
9 anddevicesthatconstitute athreattothepub-
10 liehealth.
11 (C) Making available to the Secretarv^ in-
12 formationforuseswithrespecttopromotingin-
13 novationsine\idenee-basedchnicalpracticeand
14 health care technologies under title IX of the
15 PubhcHealthSendeeAct.
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16 (b) Voluntary Participation. Subsection (a)
17 may not be construed as requiring that any health care
18 practitioner or other person participate in the program
19 undersuchsubsection.
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20 (c)CertainAuthorities. ThepostingbytheSec-
21 retaryofinfonnationonanInternetsiteundersubsection
22 (a)issubjecttothefollo^\^ng:
23 (1) The Secretary^ may not post information
24 submitted by a health care practitioner unless the
25 practitioner authorizes the Secretarj- to include in
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1 thepostingthe identityandthebusiness address of
2 thepractitioner.
3 (2) The Secretary' may impose reasonable re-
4 strictions on the format and volume ofinformation
5 tobepostedandonthefrequencyofi)ostings.
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6 (d) Criteria. Not later than one year after the
7 date ofthe enactmentofthisAct, the Secretary^shall by
8 regulationissuecriteriaforcarryingoutthissection.
9 SEC.202.JOHNEISENBERGFORUMREGARDINGSURGICAL
10 PROCEDURES.
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11 (a)InGeneral. TheSecretary',actingthroughthe
12 Commissioner of Food and Drugs, shall (directly or
13 through contract) establish a program under which the
14 followingoccur:
15 (1) HealthcarepractitionerssubmittotheSec-
16 retard' information obtained in the course of their
17 professional practices regarding surgical procedures.
18 (2) TheSecretarymaintainstheinformationre-
19 ceivedunderparagraph (1); makessuchinformation
20 availabletohealthcarepractitionersandthegeneral
21 pubhc through one or more Internet sites; and re-
22 ceives, maintains, and makes availablethrough such
23 site appropriate comments andinformationpro\ided
24 inresponsetosuchinformation.
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1 (3) The Secretarycarries out paragraph (2) m
2 a manner reasonably calculated to pro\ide a forum
3 forobtainingand disseminatinginformation, includ-
4 ingclinicaldata,towardthefblloA\inggoals:
5 (A) Identifying innovative surgical proce-
6 dures.
7 (B) Identifving surgical procedures that
8 constituteathreattothepublichealth.
9 (C) Maldng available to the Secretary' in-
10 formationforuseswithrespecttopromotingin-
11 novationsinevidence-basedchnicalpracticeand
12 health care technologies under title IX of the
13 PubhcHealthServiceAct.
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14 (b) Voluntary Participation. Subsection (a)
15 may not be construed as requiring that any health care
16 practitioner or other person participate in the program
17 undersuchsubsection.
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18 (c)CertainAuthorities. ThepostingbytheSec-
19 retaryofinformationonanInternetsiteundersubsection
20 (a)issubjecttothefollowing:
21 (1) The Secretary^ may not post information
22 submitted by a health care practitioner unless the
23 practitioner authorizes the Secretary^ to include in
24 the postingthe identityandthebusiness address of
25 thepractitioner.
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