This piece was originally published in the February 2017 issue of electroindustry.
Joe Robinson, Senior Vice President of Health Systems Solutions, Philips Healthcare, and Chairman, MITA Board of Directors
The Medical Imaging & Technology Alliance (MITA) is well-positioned to lead efforts that will leave a positive and lasting impact on the medical imaging technology industry. MITA’s 2017 strategic priorities reflect these opportunities:
Permanently repeal medical device tax
The medical device tax imposes a $29 billion excise tax on companies producing innovative medical devices crucial to effective and efficient patient healthcare. This tax stifles innovation through research and development and costs thousands of jobs. MITA supports permanent repeal through legislation and will continue to support policies to invest in innovation and create jobs.
Adopt uniform standards for medical imaging service providers
Surprisingly, only medical device service activities performed by medical device manufacturers are regulated by the Food and Drug Administration (FDA). Non-manufacturer service activities do not have the same oversight and are not held to the same quality, safety, and regulatory requirements. This has resulted in serious patient safety and device performance issues. MITA pursues opportunities to standardize best practices and urges the FDA to apply existing servicing standards to all providers who service medical devices.
Ensure patient access to medical imaging
Ultrasound, computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), positron emission tomography/computerized tomography (PET/CT), and single photon emission computed tomography (SPECT) are invaluable technologies used in cancer screening, diagnosis, staging, surveillance, and therapy monitoring. Reimbursement for these services has come under intense pressure. MITA seeks to work with public and private payers for broad coverage and reimbursement to ensure that patients get access to the right scan at the right time.
Promote cybersecurity for medical imaging
Medical imaging devices are subject to increased threats to software, hardware, and data security. As devices become increasingly connected to networks, security risks move beyond the system to intrusions across digital networks. Advancing cybersecurity measures within healthcare relies on a whole community approach, requiring manufacturers, installers, service staff, and healthcare providers to accept shared ownership and responsibility. MITA seeks to foster collaboration with all stakeholders through best practices and standards development such that current and emerging threats can be appropriately addressed across the life cycle of imaging devices—from design to installation through end of life.
Develop standards that ensure patient safety and timely access to market: Standards ensure the safety of patients and equipment operators, as well as efficient and timely market access for products. MITA continues to be the “gold standard” in standards development for the medical imaging industry. MITA will pursue opportunities to promote standards that improve patient safety and play a vital part in the design, production, and distribution of products destined for both national and international commerce.
Improve the regulatory environment to promote growth and innovation
Because all MITA member products are either approved or cleared by the FDA, it is important to engage with FDA officials and provide constructive feedback on regulatory proposals. MITA’s goal is to support a fair and equitable regulatory environment that ensures growth and innovation in medical imaging.
Remove barriers and reduce costs in overseas markets
MITA members are global in scope, and their products are highly regulated at each stage of the product lifecycle. This makes engagement in global activities critical for success. MITA works with high-level U.S. government officials to obtain favorable trade policy and international agreements; takes a leadership role in the Global Diagnostic Imaging, Healthcare ICT, and Radiation Therapy Trade Association (DITTA) to tackle global regulatory issues; and showcases the value of medical imaging to the non-government organization community.