FDA’s Vision of Health IT - Montgomery County s Vision of Health IT Roselie A. Bright, ScD ......

1

FDA’s Vision of Health IT Roselie A. Bright, ScD, MS, PMP

Program Manager Office of Informatics and Technology Innovation

Office of Operations Food and Drug Administration (FDA)

[email protected]

2014 GovConNet Procurement Conference hosted by

the Montgomery County Chamber of Commerce (MCCC) and

Congressman Chris Van Hollen

May 16, 2014

Topics

•  Introduc:on: the vision

•  Regula:on of Health IT §  FDA's FDASIA Health IT Report §  So?ware that aids clinical interpretaBon and diagnosis

•  Enabling more sophis:cated Health IT §  openFDA §  "Smart" and fast digiBzaBon of paper reports §  Standards for idenBty §  SenBnel IniBaBve §  Novel adverse event surveillance methods §  ParBcipaBon in Health IT iniBaBves

2

Speaker

•  MoCo resident, 24 years •  Recent local medical emergency •  Personal Public Service Announcement:

§  Most people with a blood clot in their leg (Deep Vein Thrombosis = DVT) don’t have any signs or symptoms, unBl part of the clot moves to their lungs (Pulmonary Embolism = PE) and quickly threatens death!

•  PE: 20% die right away; 40% die within 3 months. •  PE caused by DVT might be responsible for > 100,000 deaths/yr, as of 2008. It could

be in the top 5 leading causes of death in the US. §  Major risk factors for un-‐hospitalized people: •  Obesity •  Cancer §  Major trigger event in un-‐hospitalized people: sicng sBll for hours (airplane rides, computer work, video games) without exercising the legs

•  Pregnancy •  Hormone therapy

•  Smoking •  Age •  Prior DVT

3

4

Data In

Inform

a:on

Out

Data Processing, Analysis, InterpretaBon; Regulatory Decisions

Report (adverse event;

study)

Ac4ve data gathering

Regulatory ac4on

Report (adverse event;

study)

Public FDA data; le=ers;

press releases

Direct informa4on transfer

Introduc:on: the vision (red dots outline every area that could benefit from Health IT)

Data CuraBon

Regula:on of Health IT

•  MoBvaBon: FDA Safety and InnovaBon Act (FDASIA) requires FDA, in consultaBon with Office of the NaBonal Coordinator for Health IT (ONC) and FCC, to develop and post:

“a report that contains a proposed strategy and recommendaBons on an appropriate, risk-‐based regulatory framework pertaining to health informaBon technology, including mobile medical applicaBons, that promotes innovaBon, protects paBent safety, and avoids regulatory duplicaBon.”

•  FDASIA Health IT Report: Proposed Strategy and RecommendaBons for a Risk-‐Based Framework, April 2014 §  hip://www.fda.gov/downloads/AboutFDA/CentersOffices/

OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/UCM391521.pdf

•  The above agencies are seeking public input on the proposals unBl 7/7/2014. §  Workshop held May 13-‐15. §  InstrucBons in Federal Register noBce:

hip://www.gpo.gov/fdsys/pkg/FR-‐2014-‐04-‐07/html/2014-‐07658.htm

5

Regula:on of Health IT: Proposed Strategy

Medical device, such as: •  Computer aided detecBon so?ware •  Remote display •  NoBficaBon of real-‐Bme alarms from bedside monitors •  RoboBc surgical planning and control

Administra:ve, such as: •  Scheduling •  Billing •  Claims processing

•  PracBce management •  Inventory management

Health management, such as: •  Health informaBon •  Data exchange •  Data capture •  Provider order entry •  PaBent ID •  PaBent matching •  Knowledge management

•  Encounter documentaBon •  Electronic access to clinical results • Most clinical decision support • MedicaBon management •  Electronic communicaBon and

coordinaBon

Health IT Func:onality Risk to Pa:ent

Safety Oversight

Limited or none

Low relaBve to benefits

Dependent on device

No addiBonal by FDA

No addiBonal by FDA

ConBnue exisBng

oversight by FDA

6

Regula:on of Health IT: Proposed Priori:es

Priority Areas I. Promote

the use of quality

management principles

II. IdenBfy, develop, and adopt standards and best pracBces

III. Leverage conformity assessment

tools

IV. Create an environment of learning and conBnual improve-‐ ment

Cri4cal Characteris4cs for each Priority Area

A risk-‐based approach can be

used.

Relevant at all stages of the

health IT product lifecycle.

Relevant to all health IT stakeholders.

Supports both innova@on and pa@ent safety.

Private sector can play a strong role. 7

Regula:on of Health IT: Addi:onal key component of the

health management health IT framework

•  Health IT Safety Center §  To be created by ONC in collaboraBon with other federal and non-‐federal stakeholders

§  Public-‐private enBty §  Convene stakeholders §  Focus on promoBng health IT as an integral part of paBent safety

§  Goal: assisBng in the creaBon of a sustainable, integrated health IT learning system that avoids regulatory duplicaBon and leverages and complements exisBng and ongoing efforts

8

Regula:on of Health IT: SoPware that aids clinical interpreta:on and diagnosis

•  So?ware is in many medical devices, including: §  Some infusion pumps §  Some blood glucose meters §  Bedside monitors §  Computer-‐aided detecBon/ diagnosis of breast cancer in screening

images §  LASIX machines §  Implantable defibrillators §  MRI machines §  DNA probes

•  RegulaBon depends on the usual classificaBon of the device. hip://www.fda.gov/MedicalDevices/DeviceRegulaBonandGuidance/HowtoMarketYourDevice/default.htm

9

Enabling more sophis:cated Health IT: openFDA

§  Currently: •  FDA.gov is cumbersome to use.

o  Searches are difficult o  User must separately search each relevant database o  Large downloadable files require relaBvely high sophisBcaBon by the user

•  NaBonal Library of Medicine, part of NIH, provides some FDA databases in easy to use format, such as DailyMed (searchable database of labels for all approved drugs)

§  OpenFDA (open.fda.gov) will launch this fall.

§  Responds to PresidenBal ExecuBve Orders and an ExecuBve Memo from the Office of Science and Technology Policy (OSTP)

10

Enabling more sophis:cated Health IT: openFDA

§  Public FDA-‐regulated product informaBon (DailyMed, adverse event reports, recalls)

§  Tools will link informaBon across FDA databases §  Data in a form that is easier to use by:

•  HIT tools/apps: encourage developers to make use of FDA data (primary moBve) o  Example 1: User types their medicaBons into a phone app and then

is noBfied if the label changes or there is a recall alert.

•  individuals: simple built-‐in tools to allow specific searches o  Example 2: User at home noBces a new rash, and goes to openFDA

to find out if this rash is listed for drugs the user takes, or if FDA has received reports of similar rashes.

11

•  Currently, FDA sBll receives lots of documents on paper

•  In one instance, FDA: §  Had a backlog of 55,000 un-‐digiBzed adverse drug event reports §  A data entry process that involved humans coding terms in the reports and typing in the codes and text.

§  FDA successfully piloted digiBzaBon of adverse drug event reports §  The vendor used a new process:

•  Scanned the document. •  Virtually “shredded” each document into fields •  Extracted and validated the data in the fields with computer algorithms and human workers, in a way that maintained the confidenBality of the report content.

•  Accuracy rate was very high.

Enabling more sophis:cated Health IT: "Smart" and fast digi:za:on of paper reports

12

Enabling more sophis:cated Health IT: Standards for Iden:ty

DUNS number, from Dun & Bradstreet •  For manufacturers, firms, distributors, and other sponsors of FDA-‐regulated products

•  For other reporters of adverse events that are a business

13


•  For medical devices: §  Unique Device IdenBfier (UDI)

•  hip://www.fda.gov/udi

•  Final rule was released 9/24/2013 •  First publicly available resource to definiBvely idenBfy a medical

device •  Phased implementa:on deadlines, all on 9/24 (selected

requirements):

UDI must be permanently marked on:

Medical Device Class

III ILSLS* II I

Labels and packages 2014 2015 2016 2018

Device itself, if to be reprocessed and re-‐used a?er first use 2016 2015 2018 2018

* Implantable, life-‐supporBng, or life-‐sustaining

14

•  Benefits of implemenBng UDI: §  Enable more rapid and precise ID of a device.

o Allow more accurate reporBng, reviewing and analyzing of adverse event reports.

o Allow manufacturers, distributors and healthcare faciliBes to more effecBvely manage medical device recalls.

§  Enable a standard and clear way to document device use in electronic health records, clinical informaBon systems, claims data, and registries. o Allow efficient safety and effecBveness monitoring of marketed devices. o  Leverage to support new uses of currently marketed devices.

§  Help address counterfeiBng and diversion. §  Help prepare for medical emergencies.

15


Substance Registra:on System (SRS) -‐ Unique Ingredient Iden:fier (UNII)

§  hip://www.fda.gov/forindustry/datastandards/substanceregistraBonsystem-‐uniqueingredienBdenBfierunii/default.htm

§  Ongoing work with other regulatory agencies and the industry to promote adopBon of ISO IdenBficaBon of Medicinal Products (IDMP) standards. As an ISO compliant system, SRS is expected to be authoritaBve source of substance informaBon for all FDA-‐regulated products

§  Allows linkage to informaBon about the same or similar substances, ingredients, and components. Useful for: o  Public transparency related to allergies and sensiBviBes o  Internal review of adverse event reports, to understand potenBal scope of problem and evaluate possible mechanisms of the adverse event

o  Internal review of applicaBon to market a new product o  InvesBgaBng potenBal adulteraBon or counterfeiBng

16


A Collabora:ve Effort •  CollaboraBng InsBtuBons

§  Academic partners: planning, safety science, operaBons, data methods, analysis methods, protocol methods

§  Data partners §  Private: Mini-‐SenBnel pilot §  Public: Federal Partners CollaboraBon

•  Industry §  ObservaBonal Medical Outcomes Partnership (OMOP), now

InnovaBon in Medical Evidence Development and Surveillance (IMEDS)

•  All Stakeholders §  Brookings InsBtuBon cooperaBve agreement on topics in acBve

surveillance •  hip://www.fda.gov/Safety/FDAsSenBnelIniBaBve/default.htm

17

Enabling more sophis:cated Health IT: Sen:nel Ini:a:ve

Enabling more sophis:cated Health IT: Sen:nel Ini:a:ve– Mini-‐Sen:nel

•  Overall purposes: §  Evaluate occurrences of parBcular diagnoses, health outcomes, and/or

adverse events that FDA is concerned about §  Evaluate impact of regulatory acBon FDA has taken

•  Funded via contract •  All reports are publicly available for free

§  StaBsBcal methods §  Common data model §  IdenBficaBon and validaBon of health outcomes methods §  Results of studies

•  Public comments are someBmes sought •  Protocols are available for anyone to use on their own data •  www.mini-‐senBnel.org

18

19

1-‐ User creates and submits query (a computer program) 2-‐ Data partners retrieve query 3-‐ Data partners review and run query against their local data 4-‐ Data partners review results 5-‐ Data partners return summary results via secure network/portal 6-‐ Results are aggregated

Enabling more sophis:cated Health IT: Sen:nel Ini:a:ve– Mini-‐Sen:nel

Distributed Analysis

FDA is exploring: •  Key terms used in social media or internet searches •  Methods that don’t pre-‐suppose the range of adverse events,

that can be used real-‐Bme by partners in their electronic health record databases to detect that something new is occurring

•  Analogous to so?ware that IT security departments use to detect unwanted IT system intrusions, or that NASA uses to make sure rockets are sBll fine during the pre-‐launch and launch phases, etc.

•  Data partners would do the monitoring and then noBfy FDA and each other.

20

Enabling more sophis:cated Health IT: Novel adverse event surveillance methods

Enabling more sophis:cated Health IT: FDA par:cipa:on in Health IT groups/ ini:a:ves

•  Federal-‐level §  Health IT R&D Senior Steering Group §  Federal Health Architecture

•  Department-‐level (Department of Health and Human Services) §  CMS/ONC Meaningful Use §  ONC Health InformaBon Exchange §  PaBent-‐Centered Outcomes Research (PCOR) Trust Fund Inter-‐Agency Working Group

•  Private-‐public §  Center of Excellence in Regulatory Science and InnovaBon (CERSI) at U Maryland in College Park and BalBmore

§  Health Level Seven InternaBonal §  Healthcare InformaBon and Management Systems Society (HIMSS)

21

FDA’s Vision of Health IT - Montgomery County s Vision of Health IT Roselie A. Bright, ScD ......

Documents

Transcript of FDA’s Vision of Health IT - Montgomery County s Vision of Health IT Roselie A. Bright, ScD ......