WE L COME AND I NT RODUCT I ONS Ja me s T c he ng , M.D. Jo - PowerPoint PPT Presentation

S.M.A.R.T. Medical Device Informatics Think Tank Specific, Measurable, Achievable, Results-Oriented, Time Bound Collaboration WE L COME AND I NT RODUCT I ONS Ja me s T c he ng , M.D. Jo se ph P. Dro zda , Jr., M.D. T e rrie L . Re e d, M.S. JO IN th e C o n v e rs a tio n o n Tw itte r @ M D e p iN e t_ p p p # M D Ep iN e t_ M TG fo r m e e tin g q u e s tio n s / c o m m e n ts

SMART INF ORMAT ICS T HINK T ANK PL ANNING MDE PiNe t F DA CDRH Se nior L e ade r ship DCRI Coor dinating Ce nte r  E xe c utive Pa rtne rs  Britt Ba rha m T hink T ank Planning T e am (>50)  Mic he lle Sme re k  Da nic a Ma rina c -Da b ic Pr e se nte r s/ Br e akout  Princ e ss Grime s  Mitc he ll K ruc o ff L e ade r s/ Sc r ibe s/ F loate r s  Re b e c c a Wilg us  Art Se dra kya n AHRQ  We nd y Sprintz  Sha ro n-L ise No rma nd  E lise Be rline r  Ja me s Nie b e rding  E xe c utive Co mmitte e  Pub lic a tio ns Co mmitte e  We b site T e a m  Ab b y I sa a c s  Ma tthe w Cio ffi  Swa ti Cha kra b o rty  Sa ndi Mc Da ne l

Pe o ple who re c e ive c a re o r suppo rt the c a re o f o the rs* * F r om “ONC Conne c ting He alth and Car e for the Nation A Shar e d Nationwide Inte r ope r ability Roadmap” Dr aft v.1

Pe o ple a nd o rg a niza tio ns tha t de live r c a re a nd se rvic e s

Org a niza tio ns tha t pa y fo r c a re

Pe o ple a nd o rg a niza tio ns tha t suppo rt the pub lic g o o d

Pe o ple a nd o rg a niza tio ns tha t g e ne ra te ne w kno wle dg e , whe the r re se a rc h o r q ua lity impro ve me nt

Pe o ple a nd o rg a niza tio ns tha t pro vide He a lth I T c a pa b ility

Pe o ple a nd o rg a niza tio ns tha t suppo rt the pro duc tio n a nd distrib utio n o f me dic a l pro duc ts

Pe o ple a nd o rg a niza tio ns tha t de ve lo p a nd ma inta in sta nda rds

8:45-10:00 – Plenary Session: Building a SMART Medical Device Data Capture Infrastructure Purpose of this Session: To highlight key National initiatives that will inform prioritization of Think Tank projects and set a common vision and goals for expected outcomes over the two-day session

8:45-10:00 – Plenary Session: T he impo rta nc e o f hig h q ua lity da ta to the suc c e ss o f F DA’ s Na tio na l Po stma rke t • Surve illa nc e Pla n: Je ffr e y Shur e n De ve lo pme nt a nd inno va tive use o f struc ture d da ta c a pture a sse ts: links to MDE piNe t • visio n a nd g o a ls: Danic a Mar inac - Dabic Ma jo r F DA-spo nso re d initia tive s • o L inks to Na tio na l Pla nning Bo a rd: Mar k Mc Cle llan o UDI Ro a dma p fo r Ado ptio n in E le c tro nic He a lth I nfo rma tio n: Mar k Mc Cle llan o De vic e I de ntific a tio n a s pa rt o f a n o ve ra ll He a lth I T Pla n: Ste ve n Posnac k o PE W-ONC-F DA Pub lic Me e ting o n Re a lizing the Be ne fits o f UDI I n He a lth Ca re : Josh Rising Visio n a nd Go a ls fo r T he T wo -Da y T hink T a nk: Jose ph Dr ozda •

USE CASE ONE : CAPT URI NG DE VI CE AT T RI BUT E S 10:00-11:00 – Use Case One - Captur ing de vic e attr ibute s Se ssion L e ade r : Mike Sc hille r De sc riptio n o f Use Ca se : Ca pture a nd e xc ha ng e o f c o re de vic e ide ntific a tio n info rma tio n within the he a lthc a re pro vide r e nviro nme nt fo r use a s a ma ste r so urc e to c o nsiste ntly ide ntify the de vic e in a ll do wnstre a m syste ms a nd pro c e sse s. Using the Da ta in the F DA Glo b a l Uniq ue De vic e I de ntific a tio n Da ta b a se (GUDI D): Indir a Kondur i Ma nufa c ture r Pe rspe c tive o n c a pturing de vic e info rma tio n: Cor win He e Sta nda rds De ve lo pme nt Org a niza tio n wo rk o n de vic e ide ntific a tio n: Paul Knapp De vic e le sso ns to b e le a rne d fro m me dic a tio n da ta c a pture : Julie Suko

USE CASE T WO: L I NK I NG PAT I E NT AND DE VI CE 11:00-12:15 – Use Case T wo - Making the link be twe e n the patie nt and de vic e Se ssion L e ade r : Natalia Wilson/ Jose ph Dr ozda De sc riptio n o f Use Ca se : L ink o f struc ture d de vic e a nd pa tie nt da ta during a pro c e dure into a pa tie nt-de vic e da ta c a pture syste m inc luding a b ility to e xc ha ng e da ta with o the r syste ms tha t suppo rt linka g e b e twe e n pro c e dure , de vic e a nd pa tie nt.  Struc ture d de vic e re po rting a s pa rt o f pa tie nt c a re : Jame s T c he ng  Ca pturing struc ture d de vic e da ta a t the VA: Paul Var osy  L inking de vic e da ta to K a ise r E HR: Re be c c a L ove  L inking de vic e da ta to Me rc y Ca th L a b : Cur tis Dudle y/ Jose ph Dr ozda  I mpla nt tra c king a t Ma yo Clinic Arizo na – Natalia Wilson

USE CASE T HRE E : DAT A F ROM I MPL ANT ABL E DE VI CE OUT PUT 12:45-1:30 – Use Case T hr e e : Obtaining str uc tur e d de vic e data fr om implantable de vic e output Se ssion L e ade r : T e r r ie Re e d De sc riptio n o f Use Ca se : E xc ha ng e o f de vic e info rma tio n fro m de vic e itse lf to / fro m pa tie nt- de vic e da ta c a pture syste ms  Ba c kg ro und o f I HE I DCO I mple me nta tio ns: David Slotwine r  Use fo r impla nta b le c a rdia c de vic e s: Manish Wadhwa  Use in pe rso na l he a lth re c o rd: Mic hae l Mir r o  L e sso ns L e a rne d fro m Me dic a l De vic e Plug n Pla y (MDPnP) a t Pa rtne rs He a lthc a re : Julian Goldman

USE CASE F OUR: DOWNST RE AM USE 1:30-2:30 – Use Case F our : E xtr ac ting str uc tur e d de vic e data c olle c te d in pr e vious use s c ase s for downstr e am syste m use Se ssion L e ade r : Mar c Ove r hage De sc riptio n o f Use Ca se : I nput a nd e xc ha ng e o f pa tie nt a nd de vic e info rma tio n fro m so urc e syste ms to a se c o nda ry so urc e (e .g . Re g istry, AE Re po rt o r Clinic a l T ria l). T his ma y/ ma y no t inc lude a dditio n o f supple me nta l da ta fo r purpo se o f po pula ting se c o nda ry so urc e .  ONC Struc ture d Da ta Ca pture : E ve lyn Galle go  Co o k Me dic a l – E HR Re g istry Da ta : Ne al F e ar not/ T e d He ise  ACC Pro je c t to pull da ta to I CD Re g istry: Dino Damale s/ Kathle e n He witt/ Gane san Sr inivasan  AJRR – da ta pulle d fro m E HR to this re g istry: Car yn E tkin  F ORCE T JR: Patr ic ia F r anklin

E NVI RONME NT AL RE VI E W 2:45- 3:45 – E nvir onme ntal Re vie w: Oppor tunitie s for de vic e data e ngage me nt Se ssion L e ade r : E d Hammond Purpo se o f this Se ssio n: T o pro vide o ve rvie ws o f re la te d he a lth da ta c a pture a nd do wnstre a m a na lysis initia tive s a nd e xplo re o ppo rtunitie s fo r e ng a g e me nt o f de vic e sta ke ho lde rs a nd use c a se s in the se e ffo rts  He a lth Se rvic e s Pla tfo rm Co nso rtium: Stan Huff  Use o f So urc e Da ta in Do wnstre a m E ffo rts  Se ntine l/ PCORNE T : L e sle y Cur tis  DE L T A: F r e d Re snic / Mike Mathe ny  I nte rna tio na l Co nso rtium o f Ortho pe dic Re g istrie s (Da ta L ib ra ry): Re be c c a L ove

PANE L DI SCUSSI ON – DAY 2 PRE P 3:45-4:30 – Pane l disc ussion of obstac le s/ le ssons le ar ne d; Pr e par ation for day 2 Se ssion L e ade r : Jame s T c he ng Purpo se o f this Se ssio n: T o summa rize c o mmo n the me s he a rd in pro je c t summa rie s a nd he lp se t prio ritie s o n the mo st impo rta nt issue s to a ddre ss in Da y 2 b re a ko ut se ssio ns. Se t e xpe c ta tio ns fo r Da y 2 o utc o me s a nd ide a s fo r pa th to suc c e ss inc luding e nvisio ning the e nd to e nd e nviro nme nt  Ob sta c le s to Struc ture d De vic e Da ta Ca pture : De br a Dor e  A c linic ia n vie w o f impa c t o n wo rkflo w: De nise Downing  I ssue s with De vic e Da ta Sta nda rds Ado ptio n: Hans Buite ndijk  Wha t’ s in it fo r the C-Suite ? : Jose ph Dr ozda  Oppo rtunitie s fo r c o lla b o ra tio n with o the r initia tive s: L e sle y Cur tis