The Food and Drug Administration recently announced that the Office of the National Coordinator for Health Information Technology is launching the Sentinel Initiative with the ultimate goal of creating and implementing the Sentinel System - a national, integrated, electronic system for monitoring medical product safety.
The Sentinel System, which will be developed and implemented in stages will ultimately enable us to access the capabilities of multiple, existing data systems (e.g., electronic health record systems, medical claims databases) to augment the agency's current capability.
The goal is an understanding of adverse events resulting from treatment creating new methods of signal detection, data mining, and analysis, enabling researchers to generate hypotheses about, and confirm the existence and causal factors, of safety problems in the populations using the products.
Currently the focus has been to integrate data from various large populated databases, from MedSun ( Medical Product Product Safety Network), KIDnet (a postmarket database of pediatric ICU's and Neonatal ICU's), Heartnet (data gathered from electrophysiology laboratories), Labnet (data collected from hospital laboratories), SightNet (a collection of data from the use of ophthalmic devices), and HomeNet (a collection of data from home use devices). The FDA signed agreements with the Veterans Health Administration ( VHA) to build tools and infrastructures for evaluating the safety of drugs, biologics, and medical devices as well as the Department of Defense (DoD) for automated signal generation and data mining tools with the DoD's ALTHA electronic medical record system as well as identify influenza vaccine safety.
At the core of this collaboration is Information Technology, the (CCHIT) The Certification Commission for Healthcare Information Technology provides processes that provide interoperability for Electronic Healthcare Records (EHR). The Healthcare Information Technology Standards Panel (HITSP) provides interoperability specifications (HITSP C 32, 35, 36) to exchange patient data between Community Heath Centers they share ( HIE's or Health Care Information Exchange).
The Nationalwide Health Information Network (HHIN) is being developed to provide a national, secure and interoperable network. The network of networks will connect diverse entities at the state and regional (HIE's) that need to exchange health care information. The FDA is planning on using the HHIN existing framework to provide Sentinel access to diverse networks to retrieve data from a number of healthcare resources.
Healthcare IT services now interconnect patient health care medical devices that are local and remote to the health facility to Medical Device Data Systems (MDSS) that collect and store status and performance data from medical devices. The MDSS systems interconnect with EHR systems that connect to the Healthcare network (HIE) and the (HHIN) "network of networks" grid. The Holland & Hart Healthcare Law Blog article on Internet Medicine points out the challenges to the interoperability of medical devices to electronic health record systems and the proliferation of internet worms (Conflicker). Robert Nadler's article from RDN Consulting on Medical Devices provides a diagram and shows protocols used for the interoperability of connecting Medical Devices to the Health Care Network.
In another article from Ph.D. Rex Gantenbein from the University of Wyoming displays the Federated model of the HIE and its advantages.
Monitoring the efficiency and effectiveness of the control environment of HIE connections as well as the back end infrastructure to EHR systems and their trust relationships with medical data systems and connections to patient medical devices will require a strong information security program that is integrated within the IT Medical framework and the Medical Business supply chain. Prevention of Intrusions and Data Breaches will be an on-going lesson learned as data is liberated from applications and becomes more liquid and data silos are taken down. Medical data is valuable information for those that depend on it for survival. Imagine botnets that are able to infiltrate healthcare medical devices or has the ability to turn off medical monitoring equipment.
Links:
Health Information Technology (HealthIT).
Nationwide Privacy and Security Framework for Electronic Exchange of Individually Identifiable Health Information
The FDA Sentinel Initiative.
Common Framework for Networked Personal Health Information
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