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A warm wel­come... ...to the fourth edi­tion of the GDPR En­force­ment Track­er Re­port – the an­niversary edi­tion cel­eb­rat­ing five years of GDPR.In the five years since the GDPR be­came ap­plic­able its power­ful frame­work for im­pos­ing fines has cer­tainly helped to raise aware­ness and en­cour­age com­pli­ance ef­forts – just as the European le­gis­lat­or in­ten­ded. At the same time, the risk of fines of up to EUR 20 mil­lion or 4% of a com­pany’s glob­al an­nu­al turnover can also lead to fear and re­luct­ance or ig­nor­ance about com­pli­ance is­sues.We still be­lieve that facts are bet­ter than fear.This is why we con­tinu­ously up­date our list of pub­licly known fines in the GDPR  En­force­ment Track­er and star­ted the GDPR En­force­ment Track­er Re­port as an an­nu­al deep dive ap­proach to provide you with more in­sights in­to the world of GDPR fines.As in the three pre­vi­ous edi­tions, the GDPR En­force­ment Track­er Re­port starts with the Ex­ec­ut­ive Sum­mary (also avail­able as a PDF ver­sion), fol­lowed by the “Num­bers and Fig­ures” sec­tion and the “En­force­ment In­sights per busi­ness sec­tor” (also in­clud­ing the over­arch­ing em­ploy­ment cat­egory. The “En­force­ment In­sights per coun­try” provide back­ground on the spe­cif­ic en­force­ment frame­work un­der na­tion­al law. Some re­marks on our meth­od­o­logy can be found at the very end of the re­port.

Un­cer­tain times, an evolving leg­al frame­work: man­aging risks and en­sur­ing so­cial re­spons­ib­il­ity in the life sci­ences & health­care sec­tor The risks of AI in the fu­ture of life sci­ences came un­der the mi­cro­scope at a land­mark leg­al For­um in Septem­ber.Health­care is ra­cing ahead in ad­opt­ing new tech­no­lo­gies across drug dis­cov­ery, de­vel­op­ment, man­u­fac­tur­ing and sup­ply chain but ex­perts pre­dict a tail-whip of dis­putes and con­tract fric­tion.Di­git­al trans­form­a­tion has the po­ten­tial to im­prove every as­pect of health­care and the pharma in­dustry but it also im­pacts data pro­tec­tion, IT se­cur­ity, con­tract design, li­ab­il­ity and reg­u­la­tion.The an­nu­al CMS Glob­al Life Sci­ences and Health­care For­um brought to­geth­er high-level in­dustry and leg­al ex­perts to dis­cuss sec­tor in­tel­li­gence and best prac­tice as well as is­sues ran­ging from cy­ber breaches and crypto­cur­rency wrangles to fall-outs over trade secrets and in­tel­lec­tu­al prop­erty (IP).“AI of­fers amaz­ing op­por­tun­it­ies to ad­vance life sci­ences and ush­er in trans­form­at­ive medi­cine such as cell and gene ther­apy, im­proved dia­gnostics and ana­lyt­ics but it also comes with con­cerns as leg­al and con­trac­tu­al risks are still be­ing un­der­stood and eval­u­ated,” says Nick Beck­ett, Glob­al Co-Head of CMS Life Sci­ences & Health­care Sec­tor Group“Sci­ence and tech­no­logy are mov­ing for­ward very quickly but we are find­ing that the de­tail and strategy of what to do to mit­ig­ate risks or re­solve them is lag­ging be­hind. These are crit­ic­ally im­port­ant is­sues that com­pan­ies need to ad­dress and the For­um ex­amined the im­plic­a­tions and solu­tions.”AI is boom­ing and a re­cent re­port by ana­lysts Grand View Re­search fore­cast that the glob­al AI in health­care mar­ket will grow from its cur­rent value of $10.4 bil­lion at a com­pound an­nu­al growth rate (CAGR) of 38.4% from 2022 to 2030. AI is fast be­com­ing a sig­ni­fic­ant ele­ment of every as­pect of health­care and leg­al de­part­ments and busi­ness units are be­ing chal­lenged to re­spond.The For­um, which was held in Brus­sels and on­line on Thursday, Septem­ber 29, had a packed agenda cov­er­ing tech­no­logy trans­form­a­tion, En­vir­on­ment­al, Sus­tain­ab­il­ity and Gov­ernance, sup­ply chain dis­rup­tion, reg­u­lat­ory frame­works and the chan­ging com­mer­cial land­scape.The scale of chal­lenge was evid­enced in the re­cent CMS Tech­no­logy Trans­form­a­tion: Man­aging Risks in a Chan­ging Land­scape re­port which re­vealed that 56% of cor­por­ate coun­sel and risk man­agers ex­pect an in­crease in AI-re­lated dis­putes, while 50% be­lieve that the use of AI tech­no­lo­gies will lead to risks and dis­putes that can­not cur­rently be fore­seen.Dis­putes will be driv­en by is­sues arising from IP and trade secrets, the use of AI, smart con­tracts, crypto­cur­ren­cies and cloud ser­vices, they be­lieve.“Or­gan­isa­tions are likely to see new types of risks and dis­putes emerge from the use of new tech­no­lo­gies such as AI and crypto­cur­ren­cies. Many busi­nesses are play­ing catch-up in un­der­stand­ing the risks as­so­ci­ated with these new tech­no­lo­gies,” says Lee Gluyas, Part­ner, CMS. “Whilst no busi­ness can elim­in­ate risks com­pletely, those that think ahead, plan early and act­ively man­age risk will give them­selves a sub­stan­tial ad­vant­age.”Fea­tured key­note speak­ers from the United Na­tions Health and De­vel­op­ment Team, gen­er­al coun­sel from lead­ing pharma com­pan­ies, Bo­ston Con­sult­ing Group, fin­an­cial ser­vices mul­tina­tion­al Aon and CMS sec­tor spe­cial­ists.

The me­dia sec­tor is known to be highly com­pet­it­ive, with that com­pet­i­tion driv­ing in­nov­a­tion. Older me­dia busi­nesses have had to grapple with dis­rupt­ive new entrants. And those new entrants are con­stantly work­ing to de­liv­er bet­ter and more en­ga­ging con­tent and user ex­per­i­ences to main­tain their ad­vant­age. Di­git­isa­tion has changed how me­dia com­pan­ies in­ter­act with their audi­ence in ways we could not have ima­gined just a few years ago, but this comes with risk.This re­port is a deep dive in­to the data first pro­duced for the re­port Tech­no­logy Trans­form­a­tion: Man­aging Risks in a Chan­ging Land­scape. This saw over 500 cor­por­ate coun­sel and risk man­agers sur­veyed from mul­tiple in­dus­tries across the world. Here we look in de­tail at the 75 re­spond­ents from the me­dia sec­tor, and their per­spect­ives on the risks as­so­ci­ated with busi­ness-crit­ic­al tech­no­lo­gies, in­clud­ing emer­ging tech­no­lo­gies. What did we find? Me­dia is a dy­nam­ic sec­tor and can be an early ad­op­ter of many nov­el tech­no­lo­gies as com­pan­ies push for com­pet­it­ive ad­vant­ages to cre­ate and sat­is­fy cus­tom­er de­mand. As we look to the fu­ture, the sec­tor does seem un­der­prepared in some areas, which is a po­ten­tial cause for con­cern.Down­load the Tech­no­logy Trans­form­a­tion me­dia sec­tor re­port now to read aboutThe prin­cip­al drivers in the ad­op­tion of busi­ness-crit­ic­al tech­no­logy in the me­dia sec­tor­Con­fid­ence in man­aging tech-re­lated risks among seni­or me­dia ex­ec­ut­ivesFu­ture threats from new tech­no­lo­gies like AI and block­chain­Which plans and pro­cesses me­dia com­pan­ies are put­ting in place to pro­tect tech in­fra­struc­ture­Cul­tur­al bar­ri­ers to man­aging tech risks in the me­dia sec­tor­Preferred ap­proaches to dis­pute res­ol­u­tion in the me­dia sec­tor

Di­git­al ad­vances and in­nov­at­ive ther­apies are push­ing the bound­ar­ies of health and the leg­al world has to keep paceLife sci­ences are fizz­ing with in­genu­ity and in­nov­a­tion with re­volu­tion­ary gene and cell drug dis­cov­ery and di­git­al ad­vances push­ing the fron­ti­ers of glob­al health­care.But the trans­form­at­ive prom­ise is freighted with com­plex con­cerns over sus­tain­ab­il­ity, af­ford­ab­il­ity, di­git­al se­cur­ity, con­tracts and IP own­er­ship. The is­sues range from sci­entif­ic tech­nic­al­it­ies to ex­ist­en­tial and eth­ic­al ques­tions over Ar­ti­fi­cial In­tel­li­gence’s abil­ity to gen­er­ate ap­proaches free from hu­man hand.The chan­ging land­scape was brought in­to fo­cus at the CMS Glob­al Life Sci­ences and Health­care For­um 2022 where ex­perts high­lighted the chal­lenges and ex­plored guid­ing prin­ciples.The pan­el, chaired by CMS Lon­don part­ner Louise Boswell, heard that cur­rent eco­nom­ic pres­sures and geo-polit­ic­al shock­waves are ra­di­at­ing across busi­ness per­form­ance and sup­ply chains, which are cru­cial to com­mer­cial vi­ab­il­ity and the land­scape is be­ing fur­ther stressed by am­bi­tious goals to re­duce car­bon emis­sions.Laeti­tia Sz­a­ller, Gen­er­al Coun­sel & VP Busi­ness De­vel­op­ment at AM Pharma, told del­eg­ates that a new prag­mat­ism was needed when ne­go­ti­at­ing col­lab­or­a­tions with part­ner com­pan­ies and she em­phas­ised the need to cre­ate con­tracts with sup­pli­ers that are flex­ible enough to weath­er storms and pro­tect all parties from cur­rent and fu­ture pres­sures.“The real­ity is that you have to find a solu­tion,” she said. “It will come down to how do we share the risk and how do we share bur­den? Hav­ing your part­ner bleed out is not go­ing to be lead­ing to a happy end­ing.”The pan­dem­ic, the Rus­si­an in­va­sion of Ukraine have caused un­pre­ced­en­ted tur­bu­lence across sup­ply chains and Sz­a­ller ad­voc­ated for all stake­hold­ers to be in­volved in early stage dis­cus­sions to avoid the time and cost risk of chan­ging sup­ply chain part­ners be­cause of in­flex­ible agree­ments.The CMS Tech­no­logy Trans­form­a­tion: Man­aging Risks in a Chan­ging Land­scape re­port found that 56% of cor­por­ate coun­sel and risk man­agers sur­veyed were ex­pect­ing a rise in dis­putes in­volving AI over the next few years.The pan­el ses­sion also got valu­able in­sights in­to the com­plex­it­ies and dif­fi­culties of build­ing AI sys­tems in life sci­ences – the glob­al sec­tor is fore­cast to grow at 20% CAGR between 2022 and 2030 – from An­ita Prin­zie, Product Man­ager, Om­nia Tech­no­lo­gies Ma­chine Learn­ing.“We try to face the risks head on.” she com­men­ted. “We want to tap in­to the op­por­tun­it­ies to build valu­able di­git­al health apps that will sup­port much more per­son­al­ised ex­per­i­ences, which we all ac­tu­ally want.“There is more health data – just like we have in the re­tail sec­tor - but this data is very per­son­al. It's your per­son­al health data. So, when com­pan­ies ask us to help per­son­al­ise those health ex­per­i­ences, it is a yes but we have to look at the risks. We can­not jump for joy and just ap­ply whatever al­gorithm from the shelf.“It is very dif­fi­cult and is not only an AI prob­lem but an AI risk man­age­ment prob­lem.”She ad­ded that reg­u­la­tions over pri­vacy and data pro­tec­tion var­ied across coun­tries so the com­pany cre­ated core pro­grammes that can be amended for dif­fer­ent na­tions rather than con­struct new sys­tems for each coun­try.The pan­el, which in­cluded CMS part­ners Bri­an Sher and Tom De Cordi­er, dis­cussed a range of is­sues such as li­cens­ing agree­ments in a chan­ging en­vir­on­ment, in­clud­ing the freshly-min­ted sec­tor of col­lab­or­a­tions based on early stage in­nov­a­tion and re­search, ‘killer ac­quis­i­tions’, com­pet­i­tion law, reg­u­lat­ory com­plex­it­ies and IP rights.Nick Beck­ett, Glob­al Co-Head of CMS Life Sci­ences & Health­care Sec­tor Group, ob­served: “Ad­vances are com­ing thick and fast in life sci­ences so we need to make sure the leg­al sec­tor can re­spond pos­it­ively to en­sure that new tech­no­lo­gies and ther­apies get to the people that need them most.“Shar­ing sec­tor in­tel­li­gence and ex­per­i­ence is key to un­der­stand where fric­tion points arise and al­lows us to find solu­tions that em­power the sec­tor.“The en­tire CMS For­um was full of in­sights and know­ledge and we are com­mit­ted to util­ising best prac­tice and in­nov­at­ive ap­proaches to get the best for our life sci­ences and health­care cli­ents.”