Industry News

New report from DITTA underlines its commitment to cybersecurity

Chicago, IL – November 30, 2016 – DITTA, the global voice for the diagnostic imaging, radiation therapy, healthcare ICT, electromedical and radiopharmaceutical industry, re-emphasized with this publication the commitment of its company members to cybersecurity in the Medical Imaging Equipment sector. The report urges all stakeholders to be vigilant in maintaining cybersecurity measures.

The report, entitled “Cybersecurity of Medical Imaging Equipment”, is being published at a time where breaches in security may have compromised patient safety and confidentiality of patient data.

DITTA Chair, Satoshi Kimura, said; “The Medical Imaging Equipment industry takes its responsibilities in cybersecurity very seriously. The insights delivered by Big Data analysis are placing us at the threshold of major advances in care. If we are to realize this opportunity, then stakeholders must be convinced that their personal data is being handled safely and securely.” He stressed that DITTA would act as a resource for cybersecurity standards and regulations in the sector, in collaboration with regulators and professional organizations that represent medical imaging, and IT professionals

The DITTA White Paper sets out the principles of current best practices for manufacturers and suppliers. It stresses that responsibility for cybersecurity cannot lie with a single stakeholder. Manufacturers and hospital IT departments need to work hand-in-hand to implement these approaches.

This paper also points to security risks from increased connectivity. Medica Imaging Equipment, in line with all computer systems, is increasingly networked through hospital intranet and the internet. This poses its own security risks through network intrusions. The report strongly recommends establishing clearly defined processes for effective cyber prevention, and training all relevant staff to implement and maintain them effectively.

 

AHWP-DITTA Joint Session on Software as a Medical Device (SaMD)

DITTA and the Asian Harmonization Working Party (AHWP) have organised a Joint Session on Software as a Medical Device (SaMD) on the 4 Nov. 2015 – 14:00 – 18:00.

For more information, please contact DITTA or AHWP.

 

JIRA Commences 2-Year Chairmanship of DITTA

BRUSSELS, BELGIUM – DITTA, the Global Diagnostic Imaging, Healthcare IT and Radiation Therapy Trade Association, is delighted to announce that JIRA, the Japan Medical Imaging and Radiological Systems Industries Association, has commenced the 2-year tenure of Chairmanship for 2015 and 2016.
JIRA continues on leadership efforts from COCIR, the European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry, as Nicole Denjoy, COCIR Secretary General, chaired DITTA in 2013 and 2014. Nicole remains in the leadership as DITTA Vice Chair and also Gail Rodriguez, Executive Director of MITA, the Medical Imaging & Technology Alliance, remains DITTA Vice Chair
Satoshi Kimura, JIRA Executive Director and new DITTA Chair, said, “We are grateful to COCIR for their 2-year Chairmanship and proud of DITTA great achievements during that time and are ready to continue our contribution especially during the forthcoming IMDRF which will take place in Tokyo on 24-26 March 2015. This is an excellent timing as IMDRF chair also moved this year from US FDA to MHLW, PMDA”.
In the past two years, DITTA launched a new branding and a publication on Refurbishment of medical devices; welcomed ITAC within its Membership; held Seminars on International Standards in Medical Device Regulations, and on Single Audit Programme; contributed to the IMDRF Stakeholder Forum since the beginning, the Second WHO Global Forum on Medical Devices, and the China International Medical Device Regulatory Forum (CIMDR) in 2014 for the 2nd time and was recently granted NGO status with World Health Organisation.
Nicole Denjoy and Gail Rodriguez, DITTA Vice-Chairs, said, “We are looking forward to continue the efforts under the leadership of JIRA and all other DITTA members”. Nicole added “In particular, we will continue to bring a global industry voice to IMDRF, share our competencies on standardisation and look forward to intensifying our cooperation with WHO”.
The 7th edition of IMDRF will take place in Tokyo, Japan on 24-26 March 2015.  DITTA is committed to continuing its contribution to regulatory convergence at global level and will be well represented there.

DITTA Publication – Refurbishment of medical devices

Refurbishment of medical devices – Contribution to Circular Economy

PDF available here.

Interactive PDF available here.

DITTA Contribution to IMDRF Stakeholder Forum on open work items

The DITTA Contribution  to IMDRF Stakeholder Forum on open work items can be found here.

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