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Medical	Deep	Learning:
Clinical,	Technical,	&	Regulatory	Challenges
and	How	to	Overcome	Them
Devon	Bernard
VP	of	Engineering	@	Enlitic
Radiology Pathology Genomics
Pharma Insurance Consultation
AI	+	Healthcare	Landscape
Enlitic uses deep learning to help doctors
provide faster, earlier, and more accurate diagnostics.
39TH
39
SMARTEST
COMPANY
MIT Technology Review
2015
39TH
14
SMARTEST
COMPANY
MIT Technology Review
2016
WORLD
TECHNOLOGY
AWARD
Health and Medicine
2016
MOST
INNOVATIVE
COMPANIES
FastCompany
2016
€1M
GRAND
PRIZE
1st CUBE Global Fair
2017
In an internal study, Enlitic found that human radiologists take an average of 2.5 minutes (150 seconds) to interpret a chest x-ray. Enlitic’s models were found to perform the same task in 15ms. Human radiologists were measured as having an AUC of
0.72 at the task of determining whether or not a patient needed follow-up whereas Enlitic’s models had an AUC of 0.84. Performance was measured against a set of 2000 chest x-rays each read by 8 radiologists with consensus used as ground truth.
Generates a differential diagnosis from a chest x-ray.
Used as a triage tool separating normal from abnormal, or for QA.
Interprets chest x-rays
10,000 times faster
than human radiologists.
16% more accurate than
radiologists and trained to look
for rare/orphan diseases.
Chest	X-ray	Interpretation	and	Triage
Assists radiologists in detecting, further characterizing, and
diagnosing suspicious pulmonary lung nodules in Chest CTs
50% more accurate
than a panel of
expert radiologists.
Capable of finding cancer
2 years earlier
than radiologists.
Currently in clinical study
Chest	CT	Lung	Cancer	Screening
In an internal study, Enlitic achieved results that surpassed by 50% a panel of 4 radiologists’ performance in malignancy classification. The study showed that panel of 4 human radiologists had the precision of 33.7% and recall of 93.0%, while Enlitic's DL
models exhibited the precision of 56.3% and recall of 100%. This study was performed using the Lung Image Database Consortium (“LIDC”) dataset with about 1,000 studies.
99%+ accuracy in reading
radiology reports in focus areas
(chest XR and CT).
Detects diagnostic / procedural
info and tags as SNOMED,
ICD9/10, and CPT codes.
Can be used alongside imaging
models to detect overbilled
procedures.
Uses Natural Language Processing to assist medical coders in
assigning insurance and billing codes from medical reports.
Medical	Billing	and	Coding
Clinical Technical Regulatory
Challenges
Clinical	Challenges
Acquiring	Data
Where	can	I	get	data?
• Public	datasets
• National	Institute	of	Health
• National	Cancer	Institute
• Cancer	Imaging	Archive
• Research	Clinics
• Strategic	Partners
• ClinicalTrials.gov
How	can	I	copy	data?
• Might	require	anonymization
• Partner	will	likely	request	you	lead
• Check	for	existing	tools	&	standards
• Might	be	distributed
• RIS,	PACS,	EMR
• multiple	archives	over	years
• Are	transfers	a	pull	or	push?
• Might	be	slow
• cloud	transfer
• ship	SSD
Defining	Labeling	Criteria
Is	our	business	use-case	valuable?
• Get	a	clinical	research	adviser
Is	our	business	use-case	practical?
• Get	a	clinical	research	advisor
What	should	our	target	problem	be?
• Get	a	clinical	research	adviser
Find	Business	
Use-Case
Define	
Target	Problem
Define	
Labeling	Criteria
Collect	
Labels
Train	
Models
What	labels	should	we	collect?
• Get	a	clinical	research	advisor
Are	we	collecting	good	labels?
• Get	a	clinical	research	adviser
.
.
Getting	Labelers
Where	to	hire	labelers?
• Remote	part-time	/	contractors
• Residency	programs
How	to	vet	labelers?
• Test	against	golden	dataset
• Consistent	over	time
• Inter-labeler	agreement
How	to	hire	labelers?
• $$$,	equity
• research	credit,	publications
• Man	+	Machine
Collecting	Labels
What	tools	to	collect	labels?
• 3rd	party	software
• Crowdflower
• Hacks
• Spreadsheets	&	Screenshares
• Develop	in-house	tools
How	many	labels	to	collect?
• Define	budget,	stages,	&	check-ins	
upfront
Are	the	labels	good?
• Quality	Assessment
• Cross-reference
• Test	model	impact
Technical	Challenges
General	Model	Training
How	to	optimize	resource	usage?
• Job	Scheduler	(Slurm)
• Track	GPU	usage
• Consider	on-site	vs	cloud	
Debugging	tips
• Python	profilers
• Python	debugger	(pdb)
How	to	track	progress?
• Centralized	perf.	reporting
• Archive	version/iterative	perf.
• Slack	webhook notifications
Medical	Model	Training
How	to	manage	big	scans	(CTs,	MRIs)?
• Might	need	more	RAM
• Cache	data	locally
• Train	near	storage	array
How	to	securely	contain	PHI?
• Only	train	on	non-PHI	data
• Provide	separate	PHI	&	non-PHI	VPNs
• Hard	split	on	all	services
Medical	Model	Testing
Are	our	models	truly	generalized?
• Test	against	multiple	data	sources
Will	our	model	work	with	new	partners?
• Calibrate	on	partner	data
• Scanning	procedures	can	differ	by	facility
• Diagnosis	criteria	can	differ	by	facility
• Do	blind	tests	with	potential	partners
Is	our	model	output	drifting?
• Check	if	partner’s	data	
distribution	has	changed
Regulatory	Challenges
Getting	Medical	Classification
Do	we	need	regulatory	approval?
• Check	national	specifications
• Compare	for	each	use-case
• Typically	based	upon	patient	risk
• Hire	regulatory	consultants
How	to	find	good	consultants?
• Ask	your	potential	partner	for	
suggestions
Do	we	have	to	wait	for	approval?
• Ask	partner	for	iterative	phases
• Start	with	historical	/	retrospective	
work
• Progress	toward	more	invasive	
integrations
• Ask	partner	about	a	clinical	trial
Other	Certifications	/	Red-Tape
Prerequisites	to	consider
• ISO
• Privacy	Impact	Assessments
• Threat	Risk	Assessments
• Penetration	Testing
• Data	Security	Officer
• Document	policies	&	procedures
• Incident	tracking
• Monitoring	compliance
Processes	to	consider
• HIPPA	training	for	all	employees
• Partner	data	sharing	agreements
• Establish	criteria	around	what	a	
partner	is	willing	to	share
• Prevent	unexpected	future	pauses
• Partner	contractor	agreements
• Establish	what	internal	employees	
have	access	to	which	partner	
facilities,	why,	and	for	how	long
Devon	Bernard
VP	of	Engineering	@	Enlitic
devon@enlitic.com	
@devonwbernard
Thank	you!
Any	questions?

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