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Leg­al pre­ci­sion in pri­vacy, data se­cur­ity and data pro­tec­tion - Ex­pert...
Ex­pert leg­al ad­visers in Africa
Telemedi­cine law, reg­u­la­tions and de­vel­op­ments
Nick Beck­ett dis­cusses telemedi­cine with Maria González Gor­don (CMS Spain), Ree­mt Mat­th­iesen (CMS Ger­many) and Valentina Par­vu (CMS Ro­mania). In this epis­ode, we dis­cuss:the sig­ni­fic­ant growth and mar­ket op­por­tun­it­ies that telemedi­cine and di­git­al health apps presenthow bar­ri­ers to the take-up of telemedi­cine have been broken down dur­ing COV­ID-19ex­cep­tion­al per­mit­ted uses of telemedi­cine in cases of emer­gency such as pan­dem­ic­sfrag­men­ted reg­u­la­tion of telemedi­cine and di­git­al health apps in dif­fer­ent jur­is­dic­tions, with the ad­vent of spe­cif­ic reg­u­la­tion in some jur­is­dic­tion­srestric­tions on the ad­vert­ising of telemedi­cine and re­mote treat­ment­show pa­tient data is pro­tec­ted and con­fid­en­ti­al­ity pre­served in use in telemedi­cine
Product li­ab­il­ity & med­ic­al mal­prac­tice in the life sci­ences & health­care...
Nick Beck­ett talks with Alaina Wadsworth (CMS UK), Dav­id Bridge (CMS UK) and Laura Opilio (CMS Italy) on product li­ab­il­ity and med­ic­al mal­prac­tice.In this epis­ode, we dis­cuss:in­ter­na­tion­al per­spect­ives on product li­ab­il­ity riskthe li­ab­il­ity of Health Care Pro­fes­sion­als (HCPs) “play­ing out of po­s­i­tion” dur­ing COV­ID-19the risks for non-Life Sci­ences man­u­fac­tur­ers en­ter­ing the Life Sci­ences spacethe “search for a scape goat” – an easy hunt­ing ex­ped­i­tion?a double track sys­tem in Italy and com­par­at­ive per­spect­ive­sprac­tic­al ad­vice to com­pan­ies to min­im­ise riskoff-la­bel use and rel­ev­ant con­sid­er­a­tions 
Leg­al and com­mer­cial col­lab­or­a­tion dis­rup­ted: New mod­els and play­ers in...
Nick Beck­ett dis­cusses with Laurent Ro­mano (CMS France), Sarah Han­son (CMS UK/Singa­pore) and Ro­land Wir­ing (CMS Ger­many) com­mer­cial col­lab­or­a­tions.In this epis­ode, we dis­cuss:are old con­tract­ing mod­els dead?soph­ist­ic­ated new forms of col­lab­or­a­tion emer­ginga ser­vice ori­ented di­git­al ap­proach – bey­ond the pill?win-win col­lab­or­a­tions with start-up­strends to in-sour­ing in cer­tain crit­ic­al areasthe de­vel­op­ment of Centres of Ex­cel­lence and op­por­tun­it­ies for pub­lic-private part­ner­ships and con­sor­ti­um
Di­git­al Health law, reg­u­la­tions and de­vel­op­ments – Part 2
Nick Beck­ett con­tin­ues to dis­cuss di­git­al health with Rob Flaws (CMS Dubai), Ni­all Mc­Al­ister (CMS UK) and Ro­land Wir­ing (CMS Ger­many).In this second in­stal­ment, the team fo­cuses on:  an in­creas­ing de­mand for di­git­al health and in­crease in tele-con­sulta­tions and use of chat­bot­sthe di­git­al­isa­tion of health­care re­cord­sthe ap­proach of Big Tech and their pro­vi­sion of ad­vanced tech­nic­al solu­tionsdata pri­vacy re­quire­ments re­gard­ing the use of im­mense data re­serves in the pro­vi­sion of di­git­al health ser­vicesthe need to in­cor­por­ate hu­man in­sight and over­sight in­to AI sys­tem pro­cesses
A fo­cus on com­puls­ory li­cens­ing for phar­ma­ceut­ic­al com­pan­ies
Nick Beck­ett talks with Jonath­an Chu (CMS Hong Kong), Sheena Jac­ob (CMS Singa­pore) and Thomas Hirse (CMS Ger­many).In this epis­ode, we dis­cuss:the ra­tionale for com­puls­ory li­cences and the re­quire­ments for grant­ing the samethe rights of pat­ent own­ers faced with the threat of com­puls­ory li­cences­any re­quire­ment for pat­ent own­ers to also provide know-how and tech­nic­al sup­port un­der a com­puls­ory li­cence­lim­it­a­tions on ex­ploit­a­tion un­der com­puls­ory li­cences, in­clud­ing la­belling re­quire­ments and dis­tri­bu­tion chan­nel re­stric­tion­sthe use of com­puls­ory li­cences to deal with the sup­ply of med­ic­al ne­ces­sit­ies dur­ing COV­ID-19the de­bate re­gard­ing the need for COV­ID-19 vac­cine pat­ent waivers
A leg­al over­view on pub­lic pro­cure­ment for the Life Sci­ences & Health­care...
Nick Beck­ett speaks with Vir­ginie Dor (CMS Bel­gi­um), Bernt Els­ner (CMS Aus­tria) and Car­oline Hob­son (CMS UK).In this epis­ode, we dis­cuss:the im­port­ance of pub­lic pro­cure­ment in the Health­care sec­tor, rep­res­ent­ing ap­prox­im­ately 10% of GDP in the E.U.the chal­lenges for pub­lic pro­cure­ment in ex­treme and un­fore­seen emer­gen­cies, in­clud­ing COV­ID-19the scru­tiny of dir­ect awards and po­ten­tial leg­al chal­lenges and sanc­tion­sthe joint cent­ral­ised pro­cure­ment of vac­cines in short time­frames and the be­ne­fits and pit­falls of such ap­proachin what cir­cum­stances ex­clus­iv­ity, in­clud­ing due to IP rights or tech­nic­al bar­ri­ers, can jus­ti­fy derog­a­tion from pub­lic pro­cure­ment pro­ced­ureswhat changes do U.K. com­pan­ies face in pub­lic pro­cure­ment pro­ced­ures in the E.U., and vice versa, in light of Brexit
A leg­al frame­work for ad­vert­ising of medi­cines and med­ic­al devices
Nick Beck­ett dis­cusses with Dora Petra­nyi (CMS Hun­gary), Jens Wag­n­er (CMS Ger­many) and Gab­ri­ela Staber (CMS Aus­tria) the ad­vert­ising of medi­cines and med­ic­al devices provid­ing prac­tic­al in­sights and an over­view of the ap­plic­able laws. In the epis­ode, we con­sider:the com­plic­ated and fast chan­ging area of reg­u­la­tion of ad­vert­ise­ments with dif­fer­ent rules in dif­fer­ent jur­is­dic­tion­show to veri­fy that sci­entif­ic evid­ence is suf­fi­cient to sub­stan­ti­ate claim­sthe use of ad­vert­ising in so­cial me­dia and oth­er pro­mo­tion­al cam­paign­sthe ap­proach of the au­thor­it­ies to new entrants to the mar­ket in­clud­ing in times of crisisrisks as­so­ci­ated with com­pet­it­ors or con­sumer pro­tec­tion or­gan­isa­tions fil­ing claim­sthe po­ten­tial im­pact of MDR on ad­vert­ising of med­ic­al devices
Di­git­al Health law, reg­u­la­tions and de­vel­op­ments – Part 1
Nick Beck­ett dis­cusses di­git­al health with Rob Flaws (CMS Dubai), Ni­all Mc­Al­ister (CMS UK) and Ro­land Wir­ing (CMS Ger­many).In this epis­ode (Part 1), we dis­cuss:the need for col­lab­or­a­tions and to deal with a po­ten­tial clash of cul­tures in bring­ing the “di­git­al” and “health” sides of the in­dustry to­geth­erthe use of AI in track-and-trace and the search for a vac­cine for COV­ID-19the lack of clar­ity of the defin­i­tion of AIwheth­er the EC White Pa­per suf­fi­ciently provides a com­pre­hens­ive pro­pos­al for reg­u­la­tion of AI, and wheth­er new le­gis­la­tion is re­quired­where li­ab­il­ity rests in re­spect of soft­ware 
A leg­al roadmap for can­nabis law and reg­u­la­tion
Nick Beck­ett dis­cusses with Laura Opilio (CMS Italy), El­len Gielen (CMS Neth­er­lands) and Shuna Ma­son (CMS UK) how the medi­cin­al can­nabis in­dustry is de­vel­op­ing across Europe, the chal­lenges it faces and what the fu­ture might hold.  In par­tic­u­lar, we dis­cuss in this epis­ode:po­ten­tially the largest can­nabis mar­ket on the plan­et;how Moore’s law seems to ap­ply to the leg­al open­ing up by au­thor­it­ies in Europe;why there is yet to be sig­ni­fic­ant use in prac­tice;what stud­ies are needed to provide the hard sci­entif­ic evid­ence health­care pro­fes­sion­als and au­thor­it­ies need to be com­fort­able with the ef­fic­acy and safety of medi­cin­al can­nabis;wheth­er re­cre­ation­al use in cof­fee shops may be di­ver­ted for med­ic­al use;wheth­er food sup­ple­ments, cos­met­ics, drinks or even ci­gar­ettes could be an al­tern­at­ive means for pa­tients to re­ceive can­nabis for med­ic­al pur­poses.
On the Pulse
Wel­come to CMS ‘On the Pulse’ video/pod­cast series for all Life Sci­ences & Health­care pro­fes­sion­als – leg­al, com­pli­ance, reg­u­lat­ory
In­solv­ency and Re­struc­tur­ing
1.What is the primary le­gis­la­tion gov­ern­ing in­solv­ency and re­struc­tur­ing pro­ceed­ings in Kenya?The primary le­gis­la­tion gov­ern­ing in­solv­ency in Kenya is the In­solv­ency Act (No. 18 of 2015), which reg­u­lates...