- nexa - server-nexa.polito.it

Re: [nexa] occhio non vede...
by Elisabetta Biasin Feb. 21, 2022

Feb. 21, 2022

Buongiorno a tutte e tutti, Andrea, e 380°, Qui Elisabetta Biasin (ricercatrice al KU Leuven Centre for IT & IP Law), iscritta da molto alla mailing list Nexa ma in questa occasione scrivo per la prima volta 😊 Oggi intervengo con piacere e interesse perché Right to Repair, Cybersecurity e Medical Device Regulation sono argomenti a me molto molto cari e sui quali vorrei condividere alcune prospettive/ riflessioni generali. Come illustrava 380°, una serie di tematiche emergono nell'ambito dell'articolo in IEEE Spectrum, come ad esempio: i requisiti della legge sui dispositivi medici, il diritto alla riparazione o right to repair, ma anche la cybersecurity dei dispositivi medici (e ovviamente gli argomenti di solito ad essi opposti, come i diritti di proprietà intellettuale, e alla safety dei pazienti o utenti finali). Ho ricercato questi argomenti in occasione di alcuni progetti (legati all'Open Source Hardware nella sanità [1][2]) e ho l’impressione che queste tematiche abbiano molta più risonanza nel dibattito legato all'impianto normativo statunitense rispetto a quello europeo. In altre parole la conclusione a cui sono arrivata è (e sarei contenta di apprendere da chi ha diverse prospettive o informazioni): serve più dibattito per il medical device right to repair con riferimento anche alle norme UE! Qualche punto. Su Right to Repair in UE (non in generale, ma) con riferimento specifico ai dispositivi medici ho trovato pochi riferimenti o iniziative. Ad esempio in US e AUS, ho letto e consiglio ia gli articoli di Jason Koebler [3], o quanto riportato da 380 – senza poi dilungarmi sull’esistente dottrina in merito. In UE ho trovato meno. Forse in UE diventa più complesso o comunque diverso perché la normativa dei dispositivi medici combacia relativamente con quella dei consumatori. Un altro argomento che trovo interessante riguarda il controllo dei dispositivi medici -- lato end user e non. Lato end-user: penso al lavoro di Karen Sandler (Software Freedom Conservancy) [4] e mi chiedo se esistano iniziative simili in UE. Lato strutture ospedaliere: esse possono avere un ruolo nella produzione di dispositivi medici. In alcuni casi si parla di Healthcare makerspace [5], come MakerNurse o MakerHealth. Sarei curiousa di sapere se accade lo stesso in concreto in UE [6][7] e quale ruolo possono avere i maker al riguardo. Infine, per quanto riguarda la cybersecurity dei dispositivi medici in UE: In US la FDA ha pubblicato la sua prima guidance nel 2005 [8] [9]. In UE la prima guidance da parte dell’Europeo Medical Device Coordination Group è arrivata [sic!] ben oltre dieci anni dopo, alla fine del 2019 (senza menzionare che non esiste ancora una relativa a AI & medical device, rimandata dal MDCG da molto tempo) -- non che non vi fossero requisiti nella MDD, ma comunque trovo questo ritardo abbastanza indicativo. Credo quindi sarebbe utile aprire una maggiore breccia nel dibattito europeo per quanto riguarda il R2R per i dispositivi medici (& tenendo anche presente quanto cruciale si prospetta il 2022 per il Right to Repair in UE! [10]) L’avvento della pandemia/ COVID19 nei primi mesi del 2020 ci ha dato la possibilità di riflettere maggiormente sulle potenzialità della riparazione dei dispositivi medici – penso all’Ospedale di Chiari e al caso ‘Isinnova’ [11] [12] [13]. Che la si veda da una prospettiva transumanista, cyborgista, *femminista, o di human enhancement, credo sia un argomento di notevole importanza, perché i dispositivi medici constituiranno sempre più un elemento fondamentale per la quotidianità [14] di tutte.i noi. Auguro un buon inizio di settimana! Un saluto, Elisabetta Riferimenti [1] https://careables.org/ [2] Biasin et al. (2020) ‘Open Source Hardware and Healthcare Collaborative Platforms: Common Legal Challenges’ https://doi.org/10.5334/joh.31 [3] Koebler, J. (2020). Hospitals need to repair ventilators. Manufacturers are making that impossible https://www.vice.com/en/article/wxekgx/hospitals-need-to-repair-ventilators… [4] Si veda ad es: https://www.law.kuleuven.be/citip/en/citip-conferences/lailec/lailec-2021/s… [5] The Medical Futurist. (2018) A Revolution in Access to Healthcare: DIY Labs and Makerspaces. https://medicalfuturist.com/revolution-access-healthcare-diy-labs-makerspac… [6] Oltre a quanto evidenziato da Larsson et al. in: ‘Makerspaces and clinician innovation in Swedish hospitals’, doi:10.1016/j.respol.2017.11.006 [7] Al riguardo, ne ho scritto qualche nota in (p. 17): Careables Validation and Policy Recommendations including Guidelines on Responsible Research and Innovation https://zenodo.org/record/4574442#.YhOAgOjMI2w [8] Si veda https://www.fda.gov/media/72154/download [9] Ne ho scritto ad esempio qui (2019): ‘Medical devices cybersecurity: a growing concern?’ https://www.law.kuleuven.be/citip/blog/medical-devices-cybersecurity-a-grow… [10] Chamberlain. E (2022) ‘2022 Should Be a Landmark Year for Right to Repair’ https://www.ifixit.com/News/56736/2022-should-be-a-landmark-year-for-right-… [11] Peters, V. (2020). Volunteers produce 3D-printed valves for life-saving coronavirus treatments https://www.theverge.com/2020/3/17/21184308/coronavirus-italy-medical-3d-pr… [12] https://www.agendadigitale.eu/sanita/stampa-3d-in-sanita-sfide-e-opportunit… [13] Kieslinger et al (2020) ‘Covid-19 Response From Global Makers: The Careables Cases of Global Design and Local Production’ https://doi.org/10.3389/fsoc.2021.629587 [14] Quigley et al. (2018) ‘Everyday Cyborgs: On Integrated Persons and Integrated Goods’ https://doi.org/10.1093/medlaw/fwy003 ______________________________________________ Ms Elisabetta BIASIN Legal Researcher KU Leuven Centre for IT & IP Law – imec [cid:image001.png@01D8273D.42665280] Sint-Michielsstraat 6 box 3443, 3000 Leuven – BELGIUM [t] +32 16 37 77 73 [e] Elisabetta.Biasin(a)kuleuven.be<mailto:Elisabetta.Biasin@kuleuven.be> [w] www.law.kuleuven.be/citip<http://www.law.kuleuven.be/citip> - www.imec.be<http://www2.imec.be/be_en/home.html> [project] In Silico World<http://insilico.world/> | CORE-MD<https://cordis.europa.eu/project/id/965246> Advanced Master (LLM) of Intellectual Property & ICT Law<http://www.law.kuleuven.be/brussel/en/education/intellectual_property_right…> CiTiP Social Media: Twitter<https://twitter.com/citip_kuleuven> – Blog<https://www.law.kuleuven.be/citip/blog/> – Linkedin<https://www.linkedin.com/groups/7460524> – Google+<https://plus.google.com/108976068267003284996/posts> ORCID ID: https://orcid.org/0000-0001-9090-3315 Pronouns: she/her/hers New! Cybersecurity of Medical Devices: Regulatory Challenges in the EU<https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3855491> -----Original Message----- From: nexa <nexa-bounces(a)server-nexa.polito.it<mailto:nexa-bounces@server-nexa.polito.it>> On Behalf Of 380° Sent: zaterdag 19 februari 2022 0:44 To: ego(a)atrent.it<mailto:ego@atrent.it>; nexa <nexa(a)server-nexa.polito.it<mailto:nexa@server-nexa.polito.it>> Subject: Re: [nexa] occhio non vede... Ciao Andrea, buogiorno nexiane per chi come me indicizza l'email a fini archivistici, e anche per fornire un minimo di contesto, sotto aggiungo qualche info La questione è (ovviamente) in-topic perché molti devices medici contengono un processore (per esempio i pacemakers, molto più diffusi) /quindi/ anche del software /riprogrammabile/ (anche la congigurazione è riprogrammazione), con TUTTE le conseguenze che questo comporta; per esempio: --8<---------------cut here---------------start------------->8--- We assess the security and privacy properties of a common ICD (implantable cardioverter defibrillator, n.d.r.) and present attacks on privacy, integrity, and availability. We show that the ICD discloses sensitive information in the clear (unencrypted); we demonstrate a reprogramming attack that changes the operation of (and the information contained in) the ICD; and we give evidence that a battery-powered ICD can be made to communicate indefinitely with an unauthenticated device, thereby posing a potential denial-of-service risk. All of our attacks can be mounted by an unauthorized party equipped with a specially configured radio communicator within range of the ICD. In our experiments, we performed attacks from distances up to several centimeters; we did not experiment with increasing this range. We also present prototype defenses against the attacks we describe. --8<---------------cut here---------------end--------------->8--- (https://www.secure-medicine.org/hubfs/public/publications/icd-study.pdf) Per rimanere su un prodotto diffusissimo come il pacemaker, chi lo impianta /sa/ che nei pazienti vanno /periodicamente/ sostituiti: https://www.theatlantic.com/health/archive/2014/02/who-killed-the-rechargea… --8<---------------cut here---------------start------------->8--- In other words, pacemakers may seem outdated battery-wise, but they're actually heading in the same direction as most wearable gadgets: Data-driven and responsive to the behaviors of the person who is wearing—or in this case implanted with—the device. --8<---------------cut here---------------end--------------->8--- cioè (dicono) non fanno pacemakers ricaricabili perché è meglio sostituirli con quelli più moderni. Perché non dovrebbe valere per /tutti/ i dispositivi, /soprattutto/ quelli "neurali"? Qualcuno ne fa anche una questione etica: --8<---------------cut here---------------start------------->8--- other issues that have been relatively neglected in the literature: potential conflicts of interest, especially those associated with industry employed allied professionals (IEAPs); unanticipated impacts of commercial competition and the continuing cycle of device improvement; risks associated with remotely accessible software; equity in access to healthcare; and questions about reuse of explanted pacemakers in low and middle income countries. --8<---------------cut here---------------end--------------->8--- (https://academic.oup.com/europace/article/20/5/739/3109178?login=false) ...perché questa etica dovrebbe valere solo per il pacemakers?!? Il movimento Right To Repair spiega bene il problema con i medical devices e le apparecchiatire diagnostiche: https://www.repair.org/medical ...perchè "l'agibilità" di quei devices deve essere legata INDISSOLUBILMENTE con chi li produce?!? Andrea Trentini <andrea.trentini(a)unimi.it<mailto:andrea.trentini@unimi.it>> writes: > ... e il cuore mi duole a leggere (io che posso!) questa https://spectrum.ieee.org/bionic-eye-obsolete «Their Bionic Eyes Are Now Obsolete and Unsupported» --8<---------------cut here---------------start------------->8--- Second Sight left users of its retinal implants in the dark [...] more than 350 other blind people around the world with Second Sight’s implants in their eyes, find themselves in a world in which the technology that transformed their lives is just another obsolete gadget. One technical hiccup, one broken wire, and they lose their artificial vision, possibly forever. To add injury to insult: A defunct Argus system in the eye could cause medical complications or interfere with procedures such as MRI scans, and it could be painful or expensive to remove. --8<---------------cut here---------------end--------------->8--- Wikipedia ha un articolo che parla proprio di questi prodotti: https://en.wikipedia.org/wiki/Artificial_cardiac_pacemaker > notizia di quella che "noi" (*) etichettiamo con: > > - #L3 computing agency rubata e obsolescenza "programmata" (fallisce > la ditta) > > - #L1 lock-in > > immagino valga anche per molti altri device medicali che ad un certo > punto raggiungono un /end-of-life/ e non sono più supportati (né > supportabili dato che sono iperproprietari) sì, vale per TUTTI... e non ditemi che non dipende /soprattutto/ da come vengono progettati :-) > (*) nel nostro modello di Cittadinanza Digitale e Tecnocivismo [...] Saluti, 380° -- 380° (Giovanni Biscuolo public alter ego) «Noi, incompetenti come siamo, non abbiamo alcun titolo per suggerire alcunché» Disinformation flourishes because many people care deeply about injustice but very few check the facts. Ask me about <https://stallmansupport.org>.

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GAO - Artificial Intelligence: Status of Developing and Acquiring Capabilities for Weapon Systems
by Diego.Latella Feb. 20, 2022

Feb. 20, 2022

U.S. Government Accountability Office Artificial Intelligence: Status of Developing and Acquiring Capabilities for Weapon Systems _GAO-22-104765_ https://www.gao.gov/products/gao-22-104765?utm_campaign=usgao_email&utm_con… DL -- Dott. Diego Latella - Senior Researcher CNR/ISTI, Via Moruzzi 1, 56124 Pisa, Italy (http:www.isti.cnr.it [1]) FM&&T Lab. (http://fmt.isti.cnr.it) CNR/GI-STS (http://gists.pi.cnr.it) https://www.isti.cnr.it/People/D.Latella - ph: +390506212982, fax: +390506212040 =================== Links: ------ [1] http://www.isti.cnr.it

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Feasibility study of the European Digital Skills Certificate, as Action 9 of the Digital Education Action Plan (2021-2027).
by Alessandro Brolpito Feb. 19, 2022

Feb. 19, 2022

In case someone is interested: Services - 86310-2022 - TED Tenders Electronic Daily (europa.eu) <https://ted.europa.eu/udl?uri=TED:NOTICE:86310-2022:TEXT:EN:HTML> Alessandro

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Feasibility study of the European Digital Skills Certificate, as Action 9 of the Digital Education Action Plan (2021-2027).
by Alessandro Brolpito Feb. 19, 2022

Feb. 19, 2022

Dear all, An interesting initiative as part of the EC digital education action plan Services - 86310-2022 - TED Tenders Electronic Daily (europa.eu) <https://ted.europa.eu/udl?uri=TED:NOTICE:86310-2022:TEXT:EN:HTML> Alessandro

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Survey to inform the development of the Ethical guidelines on AI and data usage in teaching and learning for educators
by Alessandro Brolpito (ETF) Feb. 19, 2022

Feb. 19, 2022

Dear all, your deep experience and views will be very much useful to properly shape AI in teaching and learning EUSurvey - Survey (europa.eu)<https://ec.europa.eu/eusurvey/runner/AIDATAsurvey> Alessandro Alessandro Brolpito (ETF) Senior Human Capital Development Expert - Digital Skills and Learning Policy and Public Outreach Department ADDRESS Villa Gualino, Viale Settimio Severo 65, I - 10133 Torino TELEPHONE +39 011 630 2279 FAX +390116302200 E-MAIL info(a)etf.europa.eu WEB http://www.etf.europa.eu

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occhio non vede...
by Andrea Trentini Feb. 19, 2022

Feb. 19, 2022

... e il cuore mi duole a leggere (io che posso!) questa (https://spectrum.ieee.org/bionic-eye-obsolete) notizia di quella che "noi" (*) etichettiamo con: - #L3 computing agency rubata e obsolescenza "programmata" (fallisce la ditta) - #L1 lock-in immagino valga anche per molti altri device medicali che ad un certo punto raggiungono un /end-of-life/ e non sono più supportati (né supportabili dato che sono iperproprietari) (*) nel nostro modello di Cittadinanza Digitale e Tecnocivismo -- |_|o|_| Andrea Trentini - http://atrent.it |_|_|o| Dipartimento di Informatica |o|o|o| Università degli Studi di Milano

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Inside Facebook's African Sweatshop
by Enrico Nardelli Feb. 18, 2022

Feb. 18, 2022

... These young Africans work for Sama, which calls itself an “ethical AI” outsourcing company and is headquartered in California. Sama says its mission is to provide people in places like Nairobi with “dignified digital work.” Its executives can often be heard saying that the best way to help poor countries is to “give work, not aid.” The company claims to have helped lift more than 50,000 people in the developing world out of poverty. ... Despite their importance to Facebook, the workers in this Nairobi office are among the lowest-paid workers for the platform anywhere in the world, with some of them taking home as little as $1.50 per hour, a TIME investigation found. The testimonies of Sama employees reveal a workplace culture characterized by mental trauma, intimidation, and alleged suppression of the right to unionize. The revelations raise serious questions about whether Facebook—which periodically sends its own employees to Nairobi to monitor Sama’s operations—is exploiting the very people upon whom it is depending to ensure its platform is safe in Ethiopia and across the continent. And just as Facebook needs them most, TIME can reveal that content moderators at Sama are leaving the company in droves due to poor pay and working conditions, with six Ethiopians resigning in a single week in January. ... “The work that we do is a kind of mental torture,” one employee, who currently works as a Facebook content moderator for Sama, told TIME. “Whatever I am living on is hand-to-mouth. I can’t save a cent. Sometimes I feel I want to resign. But then I ask myself: what will my baby eat?” ... https://time.com/6147458/facebook-africa-content-moderation-employee-treatm… -- EN ===================================================================== Prof. Enrico Nardelli Direttore Laboratorio Nazionale "Informatica e Scuola" del CINI Dipartimento di Matematica - Universita' di Roma "Tor Vergata" Via della Ricerca Scientifica snc - 00133 Roma tel: +39 06 7259.4204 fax: +39 06 7259.4699 mobile: +39 335 590.2331 e-mail: nardelli(a)mat.uniroma2.it home page: http://www.mat.uniroma2.it/~nardelli blog: http://link-and-think.blogspot.it/ ===================================================================== --

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4th Workshop on Digital Humanism - Towards a Research and Innovation Roadmap: 3-4 March 2022
by Enrico Nardelli Feb. 18, 2022

Feb. 18, 2022

We are pleased to announce our upcoming workshop (postponed from December): *4th Workshop on Digital Humanism - Towards a Research and Innovation Roadmap* Date and time: *Thursday, March 3 and Friday, March 4, 2022 from 9:00 a.m. to 6.00 p.m. CET (UTC+1)* Digital Humanism aims to ensure that the development of digital technologies focuses on human needs and interests. Following the Vienna Manifesto on Digital Humanism, this workshop will take the initiative one step further towards realizing the vision. While many of the challenges of our digital age have become evident, the solutions to overcoming them are not. Digital technologies are still disrupting our society and putting in question decade-long achievements of democracy, humanism, and the age of Enlightenment. The workshop will address how to advance digital technologies towards realizing inclusion and democratic societies. The workshop will be held as a hybrid event, on-site at the TU Wien in Vienna, Austria and online. Due to the Covid situation and limitations of in-person contacts, limited audience attendance on-site will be permitted (please contact us at dighum(a)ec.tuwien.ac.at) others interested we ask to join the workshop online via Zoom, Youtube Stream, or, for the morning sessions, via the Digital Humanism portal of our media partner Wiener Zeitung - access data see below. Information about the workshop and program: https://dighum.ec.tuwien.ac.at/dighum-2021/ To participate via Zoom go to: https://tuwien.zoom.us/j/96389928143?pwd=UU5YRkNuRmdoWHV4MFBwMWRCcUErdz09(P…: 0dzqxqiy) The talks will be live streamed and recorded on our YouTube channel: https://www.youtube.com/digitalhumanism Digital Humanism portal of Wiener Zeitung: https://www.wienerzeitung.at/dossiers/digitaler-humanismus/ We are looking forward to seeing you! The organizers Peter Knees, Julia Neidhardt, Erich Prem ----- Sign the Vienna Manifesto: https://dighum.ec.tuwien.ac.at Follow us on Twitter @DigHumTUWien ----- -- EN ===================================================================== Prof. Enrico Nardelli Direttore Laboratorio Nazionale "Informatica e Scuola" del CINI Dipartimento di Matematica - Universita' di Roma "Tor Vergata" Via della Ricerca Scientifica snc - 00133 Roma tel: +39 06 7259.4204 fax: +39 06 7259.4699 mobile: +39 335 590.2331 e-mail:nardelli@mat.uniroma2.it home page:http://www.mat.uniroma2.it/~nardelli blog:http://link-and-think.blogspot.it/ ===================================================================== --

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The end of free Google storage for education
by Giacomo Tesio Feb. 17, 2022

Feb. 17, 2022

In 2014, Google made a remarkable offer: anyone with a Google Apps for Education account in the US got unlimited storage for free. The logic was sound at the time. [...] The idea was that if you catch users when they are young, they're yours for life. The axiom had already been tested by both Apple and Microsoft, with creative types and workers in jobs with sensible shoes respectively. Google played on its own strengths as the first cloud-native platform for everyone. [...] Seven years later, Google has killed the deal. The tech giant announced the end of infinity in a blog post named, with magnificent chutzpah:, "More options for learning with Google Workspace for Education." [...] That announcement was a year ago, and gave existing users 18 months of grace, with new users denied the unlimited package from, well, now. Those with experience of academic deadlines won't be surprised that it has taken this long for lots of people to notice. [...] It has taken a while, and it's by no means universal, but the realisation that free can be very expensive is sinking in for users and suppliers alike. Sustainability is an absolute duty, in business as in everything, if you want a relationship to last. [...] In the online world, we're seeing the collapse of the hidden, unregulated market in personal data as the damage it does is exposed. Tratto da https://www.theregister.com/2022/02/14/google_free_storage_plan_ends_opinio… Giacomo

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Spanish court rejects opening code for automated public decisions
by Enrico Nardelli Feb. 17, 2022

Feb. 17, 2022

https://civio.es/novedades/2022/02/17/spanish-court-blocks-the-way-for-maki… A Spanish court has rejected the publication of source code for the software that approves applications for subsidies created to combat energy poverty. Civio, having noticed errors in its functioning, requested the code under the Transparency Law to analyse it. After a Government’s refusal, the Spanish Transparency Council also denied Civio’s access to the code on the grounds that it is protected by intellectual property rights. Now, a judge rejects its disclosure, adding that releasing the code of this programme also represents a danger to public security and national defence. ... -- EN ===================================================================== Prof. Enrico Nardelli Direttore Laboratorio Nazionale "Informatica e Scuola" del CINI Dipartimento di Matematica - Universita' di Roma "Tor Vergata" Via della Ricerca Scientifica snc - 00133 Roma tel: +39 06 7259.4204 fax: +39 06 7259.4699 mobile: +39 335 590.2331 e-mail: nardelli(a)mat.uniroma2.it home page: http://www.mat.uniroma2.it/~nardelli blog: http://link-and-think.blogspot.it/ ===================================================================== --

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