Community call: Managing Health and Technology Research Data

On Tues­day 26th Octo­ber we host­ed a com­mu­ni­ty call on ‘Man­ag­ing Health and Tech­nol­o­gy Research Data’.

The one-hour long event brought par­tic­i­pants togeth­er from var­i­ous insti­tu­tions around the world for a dis­cus­sion about med­ical device reg­u­la­tion and pub­lish­ing med­ical data.

Down­load the slides and watch the record­ing!

Getting to know participants

Uni­ver­si­ty of Tech­nol­o­gy Bio­med­ical Engi­neer­ing data stew­ard, Anne Aarts, kicked off the first ses­sion with a Men­ti dis­cus­sion to get to know our com­mu­ni­ty par­tic­i­pants.

The major­i­ty of par­tic­i­pants were research data man­age­ment sup­port staff who advise researchers about the appro­pri­ate han­dling of med­ical data.

Inter­est­ing­ly, some of the par­tic­i­pants revealed that they were not sure whether they work with med­ical data or not, giv­en the broad def­i­n­i­tion of ‘health data’ and uncer­tain­ty about what ‘health data’ is.

Oth­er chal­lenges to work­ing with health data were report­ed to relate to under­stand­ing pri­va­cy reg­u­la­tions; how to appro­pri­ate­ly store, share and reuse health data; how to make health data FAIR; and, how to cor­rect­ly anonymise/pseudonymise health data.

Session 1: Medical Device Regulation (Anne Aarts)

Anne Aarts was part of the LCRDM Task Group on Med­ical Device Reg­u­la­tion (MDR). In the first ses­sion, Anne intro­duced the Euro­pean Reg­u­la­tion that was intro­duced in May 2021.

The MDR defines a ‘med­ical device’ as any instru­ment, appa­ra­tus, appli­ance, soft­ware, implant, reagent, mate­r­i­al or oth­er arti­cle… to be used for human beings for med­ical pur­pos­es.

The task group brought var­i­ous stake­hold­ers togeth­er to cre­ate an overview of dif­fer­ent exist­ing resources that can be used to sup­port researchers using med­ical devices through­out var­i­ous stages of the research life­cy­cle.

The task group cre­at­ed a poster with ‘take home mes­sages’ that guide researchers through the process of MDR. The poster presents infor­ma­tion about:

• Prepar­ing to use a med­ical device (includ­ing infor­ma­tion about the type of med­ical device, it’s char­ac­ter­is­tics and class; how it will be used in clin­i­cal study; and, it’s devel­op­ment and use in-house or exter­nal­ly).
• Roles and respon­si­bil­i­ties (e.g. deter­min­ing who is respon­si­ble for the med­ical device with­in col­lab­o­ra­tive projects).
• Research data man­age­ment and doc­u­men­ta­tion required.
• The reg­is­tra­tion and approval process involv­ing the research from medical/ethical com­mit­tee.

The poster will be pub­lished by LCRDM soon.

Session 2: Publishing medical data (Kostas Nizamis)

Assis­tant Pro­fes­sor in Mul­ti­dis­ci­pli­nary Design at the Uni­ver­si­ty of Twente, Kostas Niza­mis, shared his per­son­al expe­ri­ence of man­ag­ing health data dur­ing his doc­tor­al research.

Kostas devel­oped a hand robot­ic exoskele­ton for patients with Duchenne Mus­cu­lar Dys­tro­phy to assist them with dai­ly activ­i­ties. This human-machine inter­face, ‘Sym­bi­Hand’, helps the patient to regain some strength in their hand to lift and move objects.

After shar­ing some back­ground to his research, Kostas talked about pub­lish­ing his dataset in 4TU.ResearchData.
He believes that:

Shar­ing data improves the qual­i­ty of work, makes it FAIR and trans­par­ent, and can result in col­lab­o­ra­tions. High qual­i­ty work should not fear expo­sure! By shar­ing data, oth­ers can reuse it with­out dupli­cat­ing efforts and recruit­ing more human par­tic­i­pants. This reduce the time, effort and resources invest­ed by researchers and par­tic­i­pants.

Reflections on the session:

A few par­tic­i­pants pro­vid­ed the fol­low­ing feed­back about the call:

• The event was rat­ed very good/excellent.
• They enjoyed the speak­ers’ pre­sen­ta­tions, con­tent of the call and inter­ac­tive Q&A ses­sions.
• The call could have been longer in dura­tion and calls could be held more fre­quent­ly through­out the year.
• Fol­low up dis­cus­sions are required on med­ical device reg­u­la­tion and pub­lish­ing med­ical health data.
• It would be nice to learn about tips, tricks and pit­falls of shar­ing data and how to plan to share data from the begin­ning of a research project.

Thank you to the speak­ers and par­tic­i­pants for an inter­ac­tive and inter­est­ing dis­cus­sion. We look for­ward to the next com­mu­ni­ty call.

If you have ideas for top­ics and would like to help us organ­ise our next com­mu­ni­ty call, please con­tact us!
We’d love to hear from you 🙂