Reflections on Improving the Interoperability and Use of the Data Dividend

Transcription

1 Reflections on Improving the Interoperability and Use of the Data Dividend Betsy L. Humphreys Acting Director National Library of Medicine National Institutes of Health Department of Health and Human Services This presentation reflects the views of the author, not official positions of NLM, NIH, or HHS. 1 1

2 Strategy for standardizing health care data (1990--)* Establish a mechanism for designating U.S. National Standards binding across US federal /state agencies AND the private sector Pick best available as starting point Broaden participation in standards development Support development (last resort!! for critical gaps), ongoing maintenance, and no/low cost distribution fees and restrictive licensing discourage use Promote use and improvement through: early Federal adoption, conformance & production testing, demonstration projects, cost/benefit research, incentives Coordinate development to achieve interlocking set of standards responsive to feedback from real use * as outlined in numerous reports and (from ) reflected in multiple Congressional and Executive Branch actions 2

3 Some Milestones a partial, NLM-centric list 1990 NLM releases 1 st ed. of Unified Medical Language System (UMLS) Metathesaurus 1996 Health Insurance Portability and Accountability Act (HIPAA) 1999 NLM begins funding LOINC 2002 NLM releases RxNorm within UMLS Metathesaurus 2003 NLM negotiates US-wide license for SNOMED CT 2004 Executive Order establishes Office of National Coordinator for Health IT(ONC) 2004 Secretary of HHS designates NLM as Coordinating Body for Clinical Terminology Standards 2005 NLM releases DailyMed (drug structured product labels submitted to FDA) 2007 International Health Terminology Standards Organization established, purchases SNOMED CT 2009 ARRA/HITECH Act establishes ONC in law, meaningful use incentives 2010 LOINC, RxNorm, SNOMED CT required for EHR certification, meaningful use 2012 NLM releases Value Set Authority Center 2015 NLM releases AccessGUDID (medical device registrations submitted to FDA) 3

4 RxNorm = significant success story Constrained universe, i.e., FDA-approved drugs Collaborative, win-win solution for HL7, NLM, FDA, VA, & commercial drug information providers Active user feedback/enhancement loop Enables analysis and aggregation of electronic medication data for US patients at multiple - but not all useful levels 4 4

5 Ranitidine 150 MG Oral Tablet 5

6 Liquid form of Ranitidine: variation in names 6

7 RxNorm: The answer to both problems Ranitidine 15 MG/ML Oral Solution Semantic Clinical Drug (SCD) Ingredient + Strength + Dose form Linked to many other levels of drug information Ingredients and ingredient IDs, brand names, NDCs, drug information provider names and IDs, prescriber & patient friendly entry vocabulary (RxTerms) Multiple existing sources of drug classes 7

8 Endorsement and use of RxNorm Centers for Medicare and Medicaid Services (CMS) Medicare Part D Model Guidelines (FRF) Clinical Quality Measures, Meaningful Use Value Sets Office of the National Coordinator (ONC) Standard for medications and medication allergies Required for Electronic Health Record certification National Council for Prescription Drug Programs (NCPDP) SCRIPT e-prescribing standard Formulary and Benefit standard Veterans Affairs Department of Defense 8

9 Features enabled by NLM drug APIs Integrating information from RxNorm (and other sources) into applications Mapping drug names and codes to RxNorm Support medication lists Link drugs to drug classes / Find all RxNorm drugs for a given class Map obsolete codes (NDC) to active drugs Available functionalities: * Track unlimited health chronicles that include symptom description, pain intensity, capture pain images, medications taking and doctors seen. * Auto retrieves Rx (RxCUI/RxNorm) 9 9

10 RxNorm Usage RxNorm downloads ~900 downloads monthly API usage > 1 billion queries in ,000 unique users monthly Users NLM applications (e.g., MedlinePlus Connect) EHR product developers Pharmacy benefit managers Healthcare insurance companies Clinical institutions Academic researchers 10 10

11 Analytics one example Multi-stakeholder, interdisciplinary collaborative to bring out the value of health data through largescale analytics OMOP Common Data Model Standard vocabularies (RxNorm for drugs) Investigation of treatment pathways For 3 chronic diseases (3 year-follow up) > 1M patients with hypertension Across multiple clinical institutions In several countries

12 But (by design) does not solve all problems, e.g., Drug indications and interactions Lack of standard drug classes Multiple classification systems for different purposes No standard definitions Limited coverage of over-the-counter and non-us drugs 12 12

13 LOINC less constrained universe Active joint development with SNOMED CT and RadLex Constantly expanding coverage in response to user feedback Adoption by large commercial labs, laboratory device manufacturers BUT Slower uptake by hospital-* and practice-based labs- SO less standard test data in clinical practice EHRs More post-processing needed to exploit data dividend * action item 13 13

14 SNOMED CT least constrained universe Novel - so far successful - international funding model Heavily employed in post-processing the data dividend, e.g., natural language processing to add value to clinical text, public health reporting, & increasingly in clinical data capture and exchange Used in clinical genetics resources, e.g., Genetic Testing Registry, ClinVar, to enable EHR connections 14 14

15 Promising research practices Using data enclaves to make more data available to researchers Thank you, CMS! Is this an answer to better research access to death data? Reproducing prospective clinical studies as computational retrospective studies Doing computational retrospective studies to judge value of doing prospective clinical studies A future pre-requisite for research funding? Adding value, e.g., standardization, to the data dividend as a by-product of research use 15 15