ABOUT US

 

Leader in Interoperability Concepts and Capabilities

The MD PnP program, established in 2004, has become a recognized leader in the development of the concepts and capabilities for integrated clinical environments. We have been working to accelerate the adoption of medical device interoperability by providing interoperability building blocks (use cases, standards, a neutral lab "test bed" environment, and open research tools) and by changing clinical and market expectations of what can be achieved.Affiliations and Program Support

The program is based at the Massachusetts General Hospital (MGH) Dept. of Anesthesia, Partners HealthCare System, and the Center for Integration of Medicine and Innovative Technology (CIMIT). Our MD PnP research program has been supported primarily by the U.S. Army Medical Materiel Agency (USAMMATelemedicine & Advanced Technology Research Center, the National Institutes of Health (NIH), National Science Foundation (NSF), and the National Institute of Standards and Technology (NIST). We have an additional affiliation with the SHARP program in the Office of the National Coordinator for Health Information Technology.

Areas of Focus

Having evolved from the OR of the Future program at MGH, the MD PnP program remains clinically grounded. Our program work to date is focused on the following areas: 

  • Standards Development - Led development within ASTM open standard for a patient-centric “Integrated Clinical Environment” (ICE) to define the conditions under which interoperability can enable device integration to create new medical device systems with greater safety and performance capabilities than any individual device – Part I of the ICE standard was published as ASTM F2761-09 (renewed 2013), and is providing a valuable framework for further defining the vision and clinical content for many other standards
  • Regulatory Pathway - Leading a working group of companies, academics, and hospitals that are developing a prototype regulatory submission to help refine the FDA clearance process (see FDA workshop content)
  • Contracting Language - Creating and refining interoperability contracting language for use by hospitals in their procurement of medical devices (MD FIRE: Medical Device Free Interoperability Requirements for the Enterprise)
  • Clinical Scenarios - Workflow analysis of clinical scenarios at the level of detail needed to inform interoperability solutions and to derive engineering requirements
  • Demonstration Implementations - Developing and showing clinical use cases in which integrating the clinical environment will improve patient safety (e.g. x-ray/ventilator synchronization and safety interlocks for patient-controlled analgesia medication delivery), and showing these at major clinical and health IT conferences
  • Open Platform Development - Developing a prototype healthcare intranet with an open ICE platform and tools to ensure safe and effective connectivity of medical equipment and decision support for clinical care

We have taken a multi-faceted approach to begin addressing key barriers to achieving interoperability, including the development and support of suitable open standards (e.g. ASTM F2761-09 Integrated Clinical Environment, or ICE), and the elicitation, collection and modeling of clinical use cases and engineering requirements for the ICE platform and “ecosystem”.

Geographically Dispersed Team

The MD PnP program leadership and “geographically dispersed team” includes not only members of Partners HealthCare clinical, information services, and clinical engineering staff but also colleagues from
other integrated healthcare delivery networks (IHDNs) such
as Kaiser Permanente; marketing and engineering staff from
medical device manufacturers; FDA and NIST staff involved in
the regulation and testing of software-based medical devices;
marketing and engineering staff representing manufacturers of
information technology-based hardware and software; and
members of academic and research communities and clinical and engineering societies.

Collaboration with Diverse Stakeholders

Our interdisciplinary, multi-institutional program team has been collaborating with diverse stakeholders including:

  • Clinicians
  • Biomedical and clinical engineers
  • Healthcare delivery organizations
  • Regulatory agencies
  • Medical device manufacturers
  • Interoperability-promoting organizations

Since the program’s inception, more than 800 clinical and engineering experts, and representatives of more than 100 companies and institutions have participated in plenary workshops/conferences, working group meetings, and focus groups to contribute to ongoing program activities and help shape the common goals.

Vendor-Neutral "Sandbox" Laboratory

The MD PnP lab provides a vendor-neutral “sandbox” to:

  • Evaluate the ability of candidate interoperability solutions to solve clinical problems
  • Model clinical use cases (in a simulation environment)
  • Develop and test related network safety and security systems
  • Support interoperability and standards conformance testing