Privacy e gestione dei dati in sanità. Chi può rilasciare la certificazione?

By 23 marzo 2017 Healtcare, IT & Management
privacy

Alla luce del nuovo regolamento europeo relativo alla protezione delle persone fisiche con riguardo al trattamento dei dati personali il processo di certificazione è uno  strumento di applicazione non obbligatoria ma volontaria che non fa venir meno la possibilità per il Garante Privacy di contestare la non conformità delle misure adottate. Il nuovo regolamento nato per stare al passo con l’evoluzione delle tecnologie e la globalizzazione della diffusione dei dati definisce cosa sia necessario prevedere per rendere sicuro un trattamento di dati e chi ha l’onere di adottare tali misure di sicurezza. Ne parliamo con l’avvocato Silvia Stefanelli che vanta una esperienza pluriennale sul tema in ambito sanitario.

Avvocato Stefanelli, tra poco più di un anno tutti i soggetti che gestiscono dati dovranno essere in regola con il nuovo regolamento 679/2016 sulla privacy. Cosa stanno facendo le Aziende?

Iniziano ad essere consapevoli che il lavoro da fare è tanto e quindi prima ci si mette in regola e meglio è. Il Regolamento introduce infatti un nuovo approccio alla gestione del dato: si passa da una disciplina di stampo un po’ burocratico a una architettura legislativa di natura molto più sostanziale. Di fatto, il titolare è chiamato a porre in essere un sistema qualità per la gestione dei dati che tratta, decidendo anche, a seconda della tipologia della natura del dato, quali misure di gestione e controllo attuare”.

Alla luce della necessità di attivare un sistema qualità, il nuovo regolamento prevede quindi la possibilità di applicare certificazioni?

Per quanto riguarda le certificazioni bisogna sottolineare che non c’è un obbligo vero e proprio. L’articolo 42 del provvedimento incoraggia l’istituzione di meccanismi di certificazione della protezione dei dati per dimostrare che i trattamenti effettuati dai titolari e dai responsabili dei trattamenti siano conformi al Regolamento. Si tratta quindi di uno strumento di applicazione non obbligatoria ma volontaria, certamente molto utile per dimostrare il rispetto del regolamento, ma che non fa venir meno la possibilità per il Garante Privacy di contestare la non conformità delle misure adottate”.

Esistono attualmente certificazioni utilizzabili?

No, a tutt’oggi non ci sono certificazioni che abbiano una valenza giuridica per regolamento sulla protezione dei dati personali”.

Ma da chi possono essere rilasciate le certificazioni?

La certificazione, secondo quanto stabilito, è rilasciata dagli organismi di certificazione o dall’autorità di controllo competente. Il punto però è un altro:  le certificazioni si rilasciano in base a criteri standard predefiniti. Tali criteri – ai sensi dell’art. 42  comma 5 del Regolamento – possono essere approvati solo dal Garante privacy e/o dal Comitato Europeo: al momento non mi risulta che né l’autorità italiana, né il Comitato Europeo abbiano emanato alcun criterio in merito. Quindi non vi possono essere certificazioni valide ai sensi del Reg 679/2016”.

Però sul sito di Accredia è stata pubblicata la notizia di una certificazione valida ai fini del regolamento 679/2016 sulla privacy rilasciata dalla società PharmaSoftFea? Come se lo spiega?

In effetti sul sito si legge che Accredia abbia approvato uno schema proprietario adottato da un organismo di certificazione (PharmaSoftFea) e lo abbia fatto diventare lo standard di riferimento per il regolamento 679/2016. Francamente non mi sembra un iter legittimo: non è chiaro infatti sulla base di quali criteri, che come ho già evidenziato attualmente non esistono, sia stato approvato questo standard. Ho anche chiesto informazioni ad Accredia in merito, ma non ho ancora ricevuto una risposta. Il problema è che attualmente la materia è ancora poco conosciuta, c’è quindi il rischio che un’azienda non abbia una piena consapevolezza di quello che sta ottenendo, e che quindi ritenga valida, ai fini dell’art. 42 del Reg. 679/2016, una certificazione che, secondo il mio parere, non ha al contrario alcuna valenza giuridica”.

Che impatto ha il nuovo regolamento sulla privacy nel settore sanitario e farmaceutico?

“Un impatto molto rilevante. In area sanitaria la più parte dei dati trattati sono dati sensibili e quindi richiedono un livello di gestione e sicurezza molto alto. Senza dubbio il nostro Garante Privacy aveva già emanato numerosi provvedimenti di area sanitaria (che restano a tutt’oggi in vigore) e che hanno già sviluppato una maggiore sensibilità nei confronti del dato che in altri paesi comunitari. In area farmaceutica e medical device il grande impatto sarà sulla gestione dei Clinical Trials,  sull’uso di tutte le apparecchiature software, sull’informazione medico scientifica tradizionale e digitale nonché sulle dichiarazioni annuali che le Aziende obbligatoriamente devono fare all’Agenzia del Farmaco. Occorrerà infatti andare ad interpretare ed applicare il nuovo regolamento 679/2016 in maniera coordinata e combinata con le norme specifiche del settore (il Dlgs  219/2006 per il farmaco e la dir 93/42/CEE per i medical device). Occorre quindi adottare un diverso approccio mentale: su questo – mi sento di dire – le aziende sono ancora molto indietro”

Fonte: dailyhealthindustry

95 Comments

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  • Draga Victor noi la Bucale luam pe buletin doar mezeluri 200 grame de cap vita furajata. Restul, le luam daca asociatia de locatari te dadea pe lista la aprozar, sau cum ii zicea.Pe mine de ex, pt ca eram f tanara, nu m-au dat, au bagat la administrator in lista o persoana in plus, si-mi luau ratia… Frumos era pe vremea aia… Dupa ce am negociat cu administratorul, mi-a dat si mie, in ultimele cateva luni din ’89 ratia. Stateam la cozi infernale, la 22 de ani, sa ma bucur de binefacerile societatii socialiste multilateral dezvoltate si inaintarea romaniei spre comunism…BLEAAAHH

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    Hi Coco! Potatoes would be great. I’m not sure about other veggies, the spices may overwhelm a bit. It’s a great idea, though… if I have a chance to try any other veggies I will let you know!

  • Amen! I can have a beer (please note the word/letter “a” for all those who believe in prohibition)after a hard day of work while watching SHU play. This is America. Now all I need is for it to be a reasonable price, but beggers can not be choosers.Did they explain or show how they cover the upper seats/level for not well attended games?BB

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    Kjempenydelige bilder, og jeg bare elsker den blÃ¥fargen i dem! 🙂 Det skipet her nederst tok jo kaka da! Mange grÃ¥ hus i Aberdeen (jeg vet), men inntil en himmel blÃ¥, du verden sÃ¥ vakkert! 🙂 Uytolig spennende flybilde ogsÃ¥!

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  • Sources SVP ?Parce que sur Wikipedia, on parle d’une fourchette (pourtant énorme ) de 65000 à 500000 caméras à Londres. On est loin de vos 2 millions Mr Sam.Sinon, quel rapport entre les caméras londoniennes et celles des affreux mollahs ? Vous pensez que l’Angleterre est une dictature ?

  • “War of Northern Agression?” You and Mr. Collins may think that’s appropriate, but it sounds like sore losers to me. Yes, those crazy Yankees who thought slavery was such a bad idea. I’ve always thought it was the “War Against the Ignorant/Racist Opressors” but hey, I’m a west coastie, what do I know?

  • I started reading "Eat, Pray, Love" when it first came out, but I became distracted by my life and put it down for a while. I found the audiobook on sale and bought it. I listened to it in the car on my long daily commute, and enjoyed it even more! It was a special treat to have someone read to me….like listening to a friend!

  • Anh, before you worry about expensive gene therapy…. you need a “awakening whip treatment” from Hong Kong officials for your unsanitary rectum resembling wrinkled throat!

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  • Also, I should report, there is a very large section of bricks near the front entrance, in which seedlings have taken root about 20 feet up. They have compromised all of the 84 year old mortar which once held the joints solidly.The entryway could cave in at any time now.While it is an amazing structure to photograph, it is extremely dangerous to enter this building. And I didn’t even mention the murder rate in this place once called “The City of the Century”.

  • Buying foreclosed homes can be pretty tricky. You are definitely old enought to buy a forclosed home. I would refer you to below article on how and where to buy a foreclosed home. Good luck!

  • I agree that this is Odd–not being a brand person, but no one is really at fault, except maybe the designers that do not purchase all of the manufactured fabric–they should then expect this to happen. it is bizarre, but aren’t we all buying patterns/following designs of SOMEONE, name brand designer or fellow burda member?

  • ZapaÅ‚ mam – tylko siÅ‚ czÄ™sto brak, ale faktycznie lubiÄ™ siÄ™ uczyć i na szczęście mam mamÄ™, która potrafi mi pomóc z każdego przedmiotu. To prawdziwe szczęście dla mnie.

  • Das sollten die Herren dann aber besser nicht in Boulder machen…@feronia: Aha, da spricht Gärtnerinnenerfahrung…@Fulano: Ãœber die Ästhetik konnte ich leider nichts recherchieren. Aber wenn die Nachbars-Damen so erscheinen, wie ich es nach deinem Kommentar vermute, werden sie wohl eher vollständig angezogen den Rasen mähen… und das ist gut so!!!

  • I for one think this is a wonderful addition to Montreal’s night sky and hope that some kind of permanent light display, which truly focuses attention on our ever-expanding and beautiful Place des Festivals, can be maintained. It just reeks of « showbiz » in the skies of Montreal. It’s a shame it has to leave.

  • I thought about the 4th Crusade, too, but decided not to wander too far afield. (Yeah, I know. Some days these threads wander so far that the Good Lord can’t find us without using a telescope.)

  • Dear Roy Tilakkumar,I assume your hospitalization expense was paid by your employer and you are concerned whether this amount will be treated as perquisite to you and taxed accordingly. I will suggest the following practical approach to your concern on perquisite — You being an employee, your employer must be providing you form-16 for financial year 2010-2011 after March 2011. You can confirm in your form-16 on whether or not your hospitalization expense will be treated as perquisite- My understanding would be same as yours, that your hospitalization expense should not be considered perquisite

  • Wydaje mi siÄ™, że wiÄ™kszym problemem niż ewentualna dwurzÄ™dowość, jest dÅ‚ugoÅ›c pÅ‚aszcza. Samemu nie bÄ™dÄ…c przesadnie wysokim unikam pÅ‚aszczy za kolana. Maksymalna dÅ‚ugość to samo kolano, preferowana – tuż przed, delikatnie zachaczajÄ…ca ewentualnie. Inaczej pÅ‚aszcz przytÅ‚acza.

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    Chào em. Em có thể liên hệ đến 2 cơ sở của trường tại Hà Nội và TP. HCM để được hỗ trợ nhé. Tại 2 cơ sở này có tuyển sinh lớp buổi tối.

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