Electronic Health Records for research and Hospital management. The "Assistance Publique - Hôpitaux de Paris" initiative

Transcription

1 Electronic Health Records for research and Hospital management The "Assistance Publique - Hôpitaux de Paris" initiative Pr Philippe Lechat Clinical Research Department, St Louis Hospital, AP-HP, Paris Hospital Network Workshop, Brussels 9 February 2017

2 AP-HP data Warehouse : from healthcare to research AP-HP = Network of 39 Public Hospitals in and around Paris («Ile de France») More than 1 million hospitalised patients / year Linked to Several Universities and many Research institute teams (Inserm, CNRS, Institut Pasteur) 30% of medical research publications in France 2

3 Assistance Publique Hôpitaux de Paris (AP-HP) Paris and Ile de France 39 University Hospitals 3

4 AP-HP data-warehouse : from healthcare to research Progressive Implementation of a same format of Electronic Health Records (EHRs) for all hospitalised patients in the different hospitals of AP-HP Creation of one unique AP-HP data-warehouse linked to the common AP-HP EHR with administrative (only one patient identification number), clinical, biological, imaging, genetic and therapeutic data (medicines, surgical acts, medical device implementation etc ) Important potential for clinical research, hospital management and patient care improvement Multiple implications : Medical / para-medical / Scientific / financial hospital management / Hospital organisation and planification / Health care / medical research / teaching policy for medical students Requires «regulation» of access and use, professional cooperation, patients information and implication 4

5 AP-HP Data Warehouse Global Architecture Data-Warehouse Patient Health care data Biology Imaging data Xray Tomodensitometry MRI, PET scan Isotope imaging Anatomo-pathology Etc Patient identification Disease classification (IDC 10) codification 5

6 AP-HP data WareHouse : Which kind of database driven studies? Studies on hospital management (performed by medical information departments) : numbers of treated patients in a given IDC10 category, therapeutic acts codification, duration of hospitalisation, evaluation of ambulatory modes of hospital care, hospital costs, medicine use and costs etc Clinical research : Information on numbers of patients corresponding to a given set of characteristics : inclusion/ non inclusion criteria in a potential clinical trial (= «feasibility» studies on numbers of patients for a future recruitement in clinical trials) Research on patient healthcare AP-HP database (anonymous data with patient de-identification) Epidemiological, pharmaco-epidemiological, medico-economic studies on patient categories that are taken in charge in several medical departments and several (all) AP-HP hospitals («multicentric AP-HP» studies) 6

7 AP-HP data warehouse : Multicentric research One investigator (medical or paramedics) wishes to perform one study Facilitating staff : One data-warehouse coordinator for each hospital (or for a group of AP-HP hospitals) Clinical reasearch unit staff (methodologists, data-scientists) Medical information of all involved health care professionals with agreement of publication rules = non opposition rules (opt out) Submission to the Scientific and Ethical review Board (AP-HP Datawarehouse Institutional Review Board) 20 members (physicians, biologists, pharmacists, surgeons, pediatricians, paramedics, patient representatives etc ), one chairman and one co-chairman Scientific, Ethics and feasibility review of each submitted research protocole May play a «diplomatic» role in case of any conflictual situation on data use 7

8 Procedure for access to the AP-HP data Warehouse to external actors/partners Good opportunity to reinforce all interactions and links between Hospitals and University (double belonging University/Hospital for medical professors in France) Many potential suties will be promoted by external academic or non academic partners for AP-HP multicentric studies : Academic partners : Other public Hospitals, Institut national de la santé et de la recheche médicale (Inserm), Centre National pour la Recherche Scientifique (CNRS), Institut national pour la recherche (INRIA), Institut Pasteur, commissariat à l énergie atomique (CEA) etc... Patient associations, pharmaceutical companies Methodology : One corresponding AP-HP physician in charge of management of external demands (Clinical Research Department) Written contracts beween external partner and APH-HP (financial compensation for expertise and work that will have to be required for the study performance) 8

9 Patient information «non opposition» principle (opt-out) Information on patient leaflets that are given to hospitalised patients at hospital entry saying that their personal medical data can be potentially used for research (without possibility of patient identification for researchers) Information on a dedicated website providing the list of accepted research protocoles : Possibility will be offered to patients to prevent their personal medical data to be used for one given research protocol It will be investigated the possibility of obtaining a written consent (opt-in) in order to : Obtain an active support from patients to such medical research Facilitate scientific publications in some international journals that could request such written informed consent 9

10 Scientific and Ethics committee 20 members: Health care professionals (physicians, pharmacists, surgeons, pediatricians, paramedics, methodologists, biostatisticians, ethics, public health) + medico-economists + patient representatives (2) One chairman, one co-chairman Two hour Meeting every month (at beginning) Validation of information documents, submission templates, questions and answers documents, website update etc The committee will analyse every submitted research protocole on Scientific interest Ethical aspects Technical feasibility according to requested data to be studied in the data warehouse The committee will ask for additional expert opinion when necessary Will use accelerated analysis procedures for some specific procedures such as feasibility studies (number of patients according to some inclusion/non inclusion criteria of a planned clinical trial) First meeting held on 13th December

11 Regulatory aspects and patient data protection rules (1) CNIL (commission Nationale Informatique et liberté) MR003 Reference methodology studies Publication in July 2016 by the french CNIL of a reference methodology (MR003) allowing non interventional researches on anonymous (with patient de-identification) data collected in databases Requires declaration and CNIL autorisation of the AP-HP Data-Warehouse Allows such researches to be performed without any further procedure if they fit with the limits and definition of the so called «MR003 CNIL Methodology» 11

12 Regulatory aspects and patient data protection rules (2) Non CNIL MR003 reference methodology studies Any personal (non anonymous) data used in the setting of vigilance studies (Pharmacovigilance, matériovigilance, cosmétovigilance, hémovigilance, biovigilance) Genetic investigations that aim at patient identification or re-identification by means of their genetic chracteristics Research requiring connexion with other administrative data-bases (SNIIRAM from Public health Insurance system - CNAMTS) Research requiring patient identification for longitudinal follow up 12

13 AP-HP data-warehouse State of the art and perspectives Planification of the common EHR for all AP-HP hospitals for Data-Warehouse set up in all AP-HP hospitals for Scientific and ethical datawarehouse (IRB) ready to start now when CNIL autorisation will be delivered Huge work of data structuration and data codification for valid clinical research (clinical data, biology, imaging data etc ) especially not only based on text analysis of patient hospitalisation reports ++ For medical research «Big data» has to mean «correct and reliable data» first!! ++ Big financial investment and AP-HP community input for such EHR and Data-Warehouse implementation («great excitment!») 13