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MITA Committees and Sections

Sections

MITA is organized by the following modality-specific sections. Industry leadership elections are held every year in the fall-for more information please contact your MITA staff contact.

  • CR-DR Group

    Industry Leadership

    • Chair: ShaeAnn Cavanagh , Agfa

    Description

    • Begin Developing Detector Standard as requested by the FDA
  • Focused Ultrasound (FUS)

    Industry Leadership

    • Chair: Hugo Embert , EDAP
    • Vice Chair: Jessica Foley , FUSF

    Description

    • Establish understanding of technology and relationships with key Congressional offices
    • Develop or support legislative or regulatory proposals to address coverage and reimbursement challenges
    • Promote value and awareness of technology through the media 
  • General Fluoroscopy Group

    Industry Leadership

    • Chair: Chris Paulik , GE

    Description

    • Publish CFR/IEC Comparison Table White Paper
  • X-Ray Section (XR)

    Industry Leadership

    • Chair: Nicole Zuk , Siemens Healthineers
    • Vice Chair: Chris Paulik , GE

    Description

    • Publish 21CFR/IEC Deviation Tables for Mammography, CT, and Radiography
    • Revise and renew appropriate XR standards
    • Provide technical support to committees as necessary
    • Continue to monitor the NYC Radiation Control Rule. 
  • Molecular Imaging Section (MO)

    Industry Leadership

    • Chair: Michael Steckner , Canon Medical
    • Vice Chair: Markus Braun , Siemens

    Description

    • Completion of revision for NU-1 Standard for gamma cameras & SPECT expected spring
    • Assess interest from members and non-members in revising NU-3 Standard for intraoperative gamma probes
    • Assess interest from members and non-members in revising NU-4 Standard for preclinical PET scanners
  • Ultrasound Section (UD)

    Industry Leadership

    • Chair: Wayne Moore , Acertara Labs
    • Vice Chair: Jodi Klessel , Siemens

    Description

    • Develop guidelines on ultrasound specification measurements
    • Engage with ultrasound related organizations on standards and guidelines
    • Work with MITA Service Committee on FDA Remanufacturing Guidance response
  • Ultrasound Technical Committee

    Industry Leadership

    • Chair: John Dennis , Siemens

    Description

    • Work on technical concerns and standards for ultrasound, like the ultrasound specifications guidance
    • Engage with IEC Ultrasound workgroup
  • Medical Imaging Informatics Section (MII)

    Industry Leadership

    • Chair: Steve Nichols , GE
    • Vice Chair: Raj Gopalan , Siemens Healthineers

    Resources

    Example Resource

    Description

    • Enable the safe exchange of healthcare information
    • Enable and promote the interoperability of medical imaging devices
    • Achieve a least-burdensome and predictable regulatory approach for imaging informatics technology and align with adjacencies like EMR/ONC
    • Shape the external space in anticipation of innovation in imaging informatics by member companies
  • Interventional Group

    Industry Leadership

    • Chair: Philip Malca , GE
    • Vice Chair: Andrew Kuhls-Gilcrist , Canon

    Description

    • Publish detector dose whitepaper
    • Publish 21CFR/IEC/IEC Deviation Tables for Interventional
    • Work with Joint Commission to clarify new fluoroscopy requirements
  • Magnetic Resonance Section (MR)

    Industry Leadership

    • Chair: Glen Sabin , GE
    • Vice Chair: Milind Dhamankar , Siemens

    Description

    • Standards Work
      • Continue work on MS-4
      • Review MS-10
      • Reaffirm/revise MS-1, MS-2, MS-3, MS-6, and MS-9
    • FDA Coils Guidance
      • Provided comments in early 2020
      • Continue monitoring
    • Finish Transmit Definitions to assist implant testing and handling.
    • Monitor Industry News from ACR, NIOSH, EMF Regulations, IEC, ISMRM, ASTM, etc.
  • CT Group

    Industry Leadership

    • Co-Chair: Kirsten Boedeker , Canon
    • Co-Chair: John Jaeckle , GE

    Description

    • Complete CFR/IEC Comparison Table
    • XR-26 Revisions
    • Continue discussions with QIBA
    • Address the Smith-Bindman Proposal for revisions

MITA Committees

MITA's committees are populated and chaired by volunteers from all member companies. If you are interested in joining any of the committees below, please contact the MITA staff liaison or email Patrick Hope.

  • Service

    Industry Leadership

    • Chair: Wayne Moore , Acertara
    • Vice Chair: Kristin Killheffer , Siemens

    Description

    • Work with MITA Government Affairs Committee to pass legislation establishing consistent quality, safety, and regulatory requirements for all servicers of medical imaging devices
    • Advocate for strong enforcement of FDA guidance on remanufacturing
    • Participate in FDA “collaborative communities” initiative on servicing/remanufacturing to promote patient safety and device performance
    • Execute media strategy to educate stakeholders about the service issue

  • PET Group

    Industry Leadership

    • Chair: Terri Wilson , Blue Earth Diagnostics
    • Vice Chair: Ann Marie Dawidczyk , Blue Earth Diagnostics

    Description

    • Achieve Separate (or “appropriate”) payment in the Medicare Hospital Outpatient Setting.  Diagnostic nuclear medicine is currently packaged into ambulatory payment classifications resulting in underpayment for the lower volume, higher priced drugs
    • Coverage: Overturn CMS National Non-coverage Determination for non-oncologic PET and improve coverage with commercial payers
    • Lessen the variability and improve the quality of FDA manufacturing inspections; improve knowledge of Part 212 regulations; implementation of FDARA Section 706 guidance
    • Create exemption for radiopharmaceuticals from legislation that mandates Medicare rebates for drug waste

  • Artificial Intelligence

    Industry Leadership

    • Chair: Camille Vidal , GE
    • Vice Chair: Pat Baird , Philips

    Description

    • Support a policy, regulatory and Standards environment that enables innovation and growth of AI in Medical Imaging
    • Promote the industry view of AI concepts to key stakeholders
    • Support development of AI strategy across MITA
    • Align with the broader healthcare AI community where beneficial

  • Government Relations

    Industry Leadership

    • Chair: Adam Fromm , GE
    • Vice Chair: Monica Volante , Philips

    Description

    • Advocate for passage of legislation that satisfies MITA’s concerns related to the servicing of medical devices
    • Educate Members of Congress and staff on MITA’s perspective on AI policy and establish MITA as the go-to resource on the subject
    • Ensure Veteran patient access to medical imaging technologies by advocating for efficient and timely VA procurement policies
    • Support payment policy beneficial to the medical imaging industry in conjunction with the Coverage & Research and Reimbursement Committees
    • Review alternative payment mechanisms in Medicare
    • Promote the medical imaging industry’s work on cybersecurity and monitor legislative activity and also develop legacy device incentive policy
    • Monitor any activity around trade policy that may impact MITA members including tariffs and possible withdrawal from the WTO Government Procurement Agreement
    • Educate relevant congressional committees on MITA’s position entering MDUFA V negotiations

  • Value, Payment & Research Committee

    Industry Leadership

    • Chair: Viviane Guay , Bracco
    • Vice Chair: Richard Frank , Siemens Healthineers

    Description

    • Promote the value of imaging to policymakers, including advancing coverage of lung, colon, and breast cancer screening
    • Advocating for process reforms to streamline path from FDA clearance/review to CMS coverage, particularly in light of challenges facing AI and PET technologies

  • Technical and Regulatory Affairs

    Industry Leadership

    • Chair: Diane Wurzberger , GE Healthcare
    • Vice Chair: Nicole Zuk , Siemens Healthineers

    Resources

    TRC Comment Tracker

    Description

    • Advance MITA Board goal of enhancing the regulatory environment to support growth and innovation in imaging
    • Develop and execute MDUFA V strategy which will deliver a predictable, consistent, and cost-effective pathway for manufacturers to deliver safe and effective medical imaging technologies to the market
    • Hold FDA accountable for its MDUFA IV commitments, including via direct engagement and leveraging Congressional oversight, as appropriate in order to ensure that the Agency’s programs are delivering values to manufacturers and patients
    • Serve as thought leader on medical imaging technical and regulatory issues as FDA, Congress, and other authorities seek to develop and implement new policy
    • Coordinate FDA engagement with other MITA Committees and Sections in order to ensure consistent messaging, including, but not limited to, such areas as standards conformity assessment, artificial intelligence, service, and the Safety and Performance Based Pathway.

  • Global Affairs Committee

    Industry Leadership

    • Chair: Elisabeth George , Philips
    • Vice Chairs: Diane Wurzburger and Robert Philips

    Description

    • Promote global harmonization on UDI through holding a workshop in China with NMPA through USTDA/ANSI if/when travel is opened again
    • IMDRF
      • Providing feedback on IMDRF Cybersecurity Working Group guidance to be published after approval by IMDRF Management Committee
      • Sponsoring workshops as a part of DITTA in Singapore at October 2020 meeting
    • Promote global harmony in auditing through providing feedback on upcoming GHTF document re: MDSAP
    • Open markets through issue tracking and providing a link for Washington Representatives group at MITA on Trade issues
    • Improve and maintain relationships with other trade associations
      • Continue quarterly check-in calls with MEDEC and ABIMED
      • CAMDI (China)
      • IMEDA (Russia)

  • State Government Relations

    Industry Leadership

    • Chair: Kristin Killheffer , Siemens
    • Vice Chair: Evan Hoffman , Philips

    Description

    • Secure exemptions for medical devices in right to repair legislation
    • Form coalitions with relevant stakeholders of interest by MITA
    • Advocate for favorable polices and regulations for the medical imaging industry in relevant legislation and regulations related to the environment, privacy, telehealth, and other issues
    • Collaborate  with appropriate MITA Committees and Sections on issues of interest
    • Engage with appropriate state regulatory entities as needed 

  • Cybersecurity

    Industry Leadership

    • Chair: Joe Burgoyne , GE Healthcare
    • Vice Chair: Jim Jacobson , Siemens

    Resources

    Jobs and Innovation
    Smart Dose One-Pager
    VA Procurement Reform One-Pager

    Description

    • Establish a regulatory, policy, and standards environment which enables the protection of device confidentiality, integrity, and availability to support patient safety and privacy;
    • Advocate manufacturer-supported best practices to harmonize regulatory requirements and customer expectations;
    • Provide manufacturers and healthcare systems increased clarity and harmonization to support efficient and effective application of standards and policies; and
    • Coordinate, collaborate, and, where appropriate, align with the broader internal and external cybersecurity policy and standards development community.

  • Standards

    Industry Leadership

    • Chair: Elisabeth George , Philips
    • Vice Chairs: James Vetro and Susumu Nozawa

    Description

    •  Engage FDA in ASCA program
    • Support DICOM through promotion general awareness and governance working principles and priorities
    • Engage in NEMA efforts to improve standards development processes
    • Support MITA sections in development of new standards

  • VA/DoD Working Group

    Industry Leadership

    • Chair: Phil Goodridge , GE Healthcare
    • Vice Chair: Frank La Spada and Tucker Scherger
  • DICOM

    Industry Leadership

    • Chair: Kevin O'Donnell , Canon

    Resources

    DICOM Website