FDA’s Pre-Certification Public Workshop: Top Line Take Aways from a Digital Health Clinician Researcher

Malinda Peeples, RN, MS, CDE
March 8, 2018

In mid-2017, the U.S. Food and Drug Admin­is­tra­tion (FDA) pub­lished the Dig­i­tal Health Inno­va­tion Action Plan. At the same time FDA’s cur­rent Com­mis­sion­er, Scott Got­tleib, MD, launched the Soft­ware Pre­cer­ti­fi­ca­tion Pilot Pro­gram, sim­ply called Pre-Cer­ti­fi­ca­tion or Pre-Cert pro­gram.

Uniqueness’s of Digital Health Technologies

This pro­gram, devel­oped under FDA’s Cen­ter for Cen­ter for Devices and Radi­o­log­i­cal Health (CDRH), rec­og­nizes the uniqueness’s of dig­i­tal health tech­nolo­gies, in their promise to improve the health of the pub­lic and the fre­quent iter­a­tive process of prod­uct improve­ments. A key aim of Pre-Cert is to assure deliv­ery and access to high-qual­i­ty, safe and effec­tive dig­i­tal health prod­ucts in a time­li­er and less bur­den­some process.

FDA’s Steps to Create Pre-Cert

To cre­ate Pre-Cert, FDA is con­duct­ing a pilot with nine com­pa­nies. The pilot, con­sid­ered a first step in this process, is designed to col­lab­o­rate with the full ecosys­tem of stake­hold­ers to achieve suc­cess. Phase 1 includ­ed site vis­its to the pilot orga­ni­za­tions. Phase 2 was a pub­lic work­shop, Fos­ter­ing Dig­i­tal Health Inno­va­tion: Devel­op­ing the Soft­ware Pre­cer­ti­fi­ca­tion Pro­gram, held Jan­u­ary 30–31, 2018.

Public Workshop on Pre-Cert

This pub­lic work­shop delved into the program’s progress and sought input from the nine pilot play­ers on their visions for the Pre-Cert pro­gram. To be clear, these nine enti­ties were not cho­sen by FDA as the first to obtain Pre-Cert sta­tus, rather they’re help­ing to design the process FDA will put in place. Com­plete archives of the work­shop are avail­able.

Top Take Aways from Malinda Peeples

Malin­da Peeples, RN, MS, CDE, WellDoc’s VP, Clin­i­cal Ser­vices, Pro­grams and Research, attend­ed this work­shop. She has been involved in the sci­ence and clin­i­cal imple­men­ta­tion of dig­i­tal health ther­a­peu­tics for near­ly a decade. She shares her top line take aways here:

  1. I was struck by the tremen­dous pas­sion and ded­i­ca­tion in the room from every attendee whether from FDA, indus­try or oth­er type of orga­ni­za­tion. There was shear excite­ment about the oppor­tu­ni­ty to be involved at the fore­front of this nov­el FDA under­tak­ing and to improve the peo­ples’ lives.
  2. By observ­ing the gamut of rep­re­sen­ta­tives in atten­dance it was clear that FDA is lever­ag­ing broad base input to devel­op a process that will be under­stood and sup­port­ed by every­one. Atten­dees rep­re­sent­ed tech­nol­o­gy ven­dors, health plan admin­is­tra­tors, pro­fes­sion­al med­ical asso­ci­a­tions, capa­bil­i­ty improve­ment mod­el experts, qual­i­ty con­sul­tants (e.g. Baldridge Per­for­mance Excel­lence Pro­gram, Capa­bil­i­ty Matu­ri­ty Mod­el Inte­gra­tion) and oth­ers.
  3. Clin­i­cal­ly val­i­dat­ed and FDA-cleared dig­i­tal ther­a­peu­tics will enable sig­nif­i­cant changes in the deliv­ery of health care from the per­spec­tives of con­ve­nience and qual­i­ty over the next decade and beyond. The rig­or with which FDA’s Pre-Cert pro­gram is being devel­oped will make it eas­i­er for clin­i­cians on the front lines of care deliv­ery to know and trust the “cer­ti­fied ven­dors” for dig­i­tal solu­tions. This will pro­vide a lev­el of con­fi­dence for clin­i­cians when they choose dig­i­tal ther­a­peu­tics and hope­ful­ly their uti­liza­tion.
  4. Once the Pre-Cert pro­gram is final­ized and launched it will be crit­i­cal that the pub­lic under­stands that a main focus of FDA’s over­sight and review of dig­i­tal health tools is to ensure the safe­ty and effec­tive­ness of these tools.
  5. It is reward­ing to observe FDA’s proac­tive and rig­or­ous approach to devel­op­ing this inno­v­a­tive and far-reach­ing pro­gram. Their com­mit­ment to co-cre­ate this pro­gram with tech­nol­o­gy ven­dors to increase the speed with which new and inno­v­a­tive solu­tions are avail­able to enhance care and out­comes is laud­able.
  6. It was clear that col­lab­o­ra­tion among all of the enti­ties involved will help achieve valu­able cross fer­til­iza­tion of knowl­edge and ideas. This should result in a well vet­ted process.

A com­pre­hen­sive FAQ on the pro­gram is avail­able.

Fol­low the evo­lu­tion of this nov­el pro­gram on Twit­ter at: #FDAPre­Cert

Check out the top line take aways from this pub­lic work­shop from dig­i­tal health inno­va­tor, Anand Iyer, PhD, MBA, WellDoc’s Chief Strat­e­gy Offi­cer.