How to address privacy, ethical and regulatory issues: Examples in cognitive enhancement, depression and ADHD Dr. Karen Rommelfanger, Director of the Neuroethics Program at Emory University Dr. Anna Wexler, Assistant Professor at the Perelman School of Medicine at UPenn Jacqueline Studer, Senior VP and General Counsel of Akili Interactive Labs Chaired by: Keith Epstein, Healthcare Practice Leader at Blue Heron Slidedeck supporting presentation and discussion during the 2019 SharpBrains Virtual Summit: The Future of Brain Health (March 7-9th). Learn more at: https://sharpbrains.com/summit-2019/

3. How to address privacy, ethical and regulatory
issues: Examples in cognitive enhancement,
depression and ADHD
Chaired by: Keith Epstein,
Healthcare Practice Leader
at Blue Heron
Dr. Anna Wexler, Assistant
Professor at the Perelman
School of Medicine at
UPenn
Jacqueline Studer, Senior
VP and General Counsel
of Akili Interactive Labs
Dr. Karen Rommelfanger,
Director of the Neuroethics
Program at Emory
University

4. .
Rethinkingandretooling
brainhealthwithethics
Karen S. Rommelfanger, PhD
Neuroethics Program Director,Center for Ethics
Departments of Neurology and Psychiatry & Behavioral Sciences

5. Neuroethics:
• The societal, ethical and legal implications of neuroscience.
• An exploration of how neuroscience reflects and informs our societal values.

6. .

7. .

8. .

9. .
Brain as Self: Roskies, 2007; Racine et al, 2010; De Jong et al, 2015 Kasulis in Swanson Brain Science and Kokoro, 2011; *Adam et al, 2015; Yang et al 2015

10. .
Brain as Self: Roskies, 2007; Racine et al, 2010; De Jong et al, 2015 Kasulis in Swanson Brain Science and Kokoro, 2011; *Adam et al, 2015; Yang et al 2015

11. .
• Societal Implications for
Brain as Self: Roskies, 2007; Racine et al, 2010; De Jong et al, 2015 Kasulis in Swanson Brain Science and Kokoro, 2011; *Adam et al, 2015; Yang et al 2015

12. .
• Neuroethical concerns have risen to the
highest levels of government. (GNS
delegates, 2018)
• Values and culture determine what kinds of
science happen and where that science can
happen.
• Gaps in understanding can lead to missed
opportunities for collaboration and
advancement to future discoveries.
• GNS unites neuroethics components of the IBI

13. future of healthcare early detection
early intervention disease modification.

14. Torous, 2016
Kirby et al, 2018

15. .
DATA
Detect 
Intervene 
Scale

16. • Continuous recording
• Surveillance:
Stigma
• Privacy,
• Treatment:
• Big Data Analytics:
• Bias
• Ownership and gatekeeping of data
Insel 2017 JAMA; Rommelfanger et al in prep
New opportunities and challenges

18. .

19. Privacy and re-identifiability
• Opportunity: continuous (vs. episodic), ubiquitous recording
• Risks:
re-identifiability

20. • Medicalization: Social process where
• Reinforcing bias: Groups and group differences are usually
defined by criteria that also have important social meanings—
i.e., by geographical boundaries, race/ethnicity, SES, or
genealogical ties.

21. • Opportunity: Surveillance, Risk Assessment and Intervention
• Risks: New unanticipated/legacy use
• Beyond the clinic might predictive information go to employers, insurance agencies,
etc.?
• What new kinds of information may be deduced/disclosed in analysis?
• No other field has the power to take and grant rights like psychiatry
• With big data, might we revisit meaning of privacy anyway?

22. • Opportunity: Surveillance, Risk Assessment and Intervention
• Risks: New unanticipated/legacy use
• Beyond the clinic might predictive information go to employers, insurance agencies,
etc.?
• What new kinds of information may be deduced/disclosed in analysis?
• No other field has the power to take and grant rights like psychiatry
• Online Platforms and Networked Harms

23. ew kinds of data.
• The purpose of big data analytics is to create new
unanticipated knowledge of already existing data
• Big data science* “changes how we know and
likewise we should expect more complicated
ethical implications of what we know”
• It is difficult to fully understand the risk of such
research as the science continues to evolve and
legacy use and ownership of data remain
unclear
*Data is now…
1. Infinitely connectable
2. Indefinitely
repurposable
3. Continuously
updatable
4. Distanced from the
context of collection
*Quoted from Metcalfe and Crawford, 2016
Opportunity: Big Data Analytics
Risks: New unanticipated use

25. Issues unique ?
Not entirely
Yes
• Informed consent

26. ?
• In US,
• In EU
• China
Japan
• It would be incorrect to suggest there are absolute differences, however relative
differences may matter in considering appropriate governance and enforcement
structures

27. 70% of the worlds populations are collectivist.
Hofstede, 2014, Wu et al, 2015; Lan, 2015
Would you use enhancers?
Society for Neuroscience, 2005, Cyranoski, Nature 2005

28. trust respect
process
empower participants

29. Thankyou.
Karen Rommelfanger, PhD
krommel@emory.edu
Resources

30. OVERSIGHT OF DIRECT-
TO-CONSUMER
NEUROTECHNOLOGIES
Anna Wexler
SharpBrains Virtual Summit
May 7, 2019

31. Talk outline
• What is direct-to-consumer (DTC) neurotechnology?
• How is DTC neurotechnology regulated in the United States?
• What are the outstanding issues regarding DTC neurotechnology?
• What should we do?

32. What is direct-to-consumer neurotechnology?
• the set of products (devices, software, applications) that are marketed to
modulate or affect brain function
• sold directly to consumers (i.e., bypassing the physician)
• appeal to the fruits of brain and cognitive science

33. • Not referring to:
• Cognitive enhancement drugs
• Neuromarketing
• Invasive/implantable technologies (i.e., brain-computer interfaces)
• Very futuristic technologies
What is direct-to-consumer neurotechnology?

34. Consumer neuroscience
technology market is predicted
to top $3 billion by 2020
(SharpBrains 2018)

35. How is DTC neurotechnology regulated (in the US)?

36. How is DTC neurotechnology regulated (in the US)?
According to Section 201(h) of the Food, Drug & Cosmetic (FD&C) Act, a
medical device is:
an instrument, apparatus, implement, machine, contrivance, implant, in vitro
reagent, or other similar or related article, including a component part, or
accessory which is:
• recognized in the official National Formulary, or the United States
Pharmacopoeia, or any supplement to them,
• intended for use in the diagnosis of disease or other conditions, or in the
cure, mitigation, treatment, or prevention of disease, in man or other
animals, or
• intended to affect the structure or any function of the body of man or
other animals, and which does not achieve its primary intended purposes
through chemical action within or on the body of man or other animals
and which is not dependent upon being metabolized for the achievement
of any of its primary intended purposes.

37. How is DTC neurotechnology regulated (in the US)?
Any app/device/product that claims to diagnose or
treat disease is regulated as a medical device by the
FDA

38. How is DTC neurotechnology regulated (in the US)?
21st Century Cures Act excludes from the definition of a
medical device any software related to “maintaining or
encouraging a healthy lifestyle”

39. How is DTC neurotechnology regulated (in the US)?
FDA will exercise enforcement discretion for low-risk
devices marketed for general wellness
• Examples of general wellness claims are those
relating to:
- mental acuity
- concentration
- problem solving
- stress and relaxation

40. How is DTC neurotechnology regulated (in the US)?
FDA will exercise enforcement discretion for low-risk
devices marketed for general wellness
• Examples of general wellness claims are those
relating to:
- mental acuity,
- concentration
- problem solving
- stress and relaxation
Consumer neurostimulation devices are not
considered low-risk, due to “the risks to a user’s
safety from electrical stimulation”

41. How is DTC neurotechnology regulated (in the US)?
Lumos Labs, Jungle Rangers,
UltimaEyes (2015-2016)

42. How is DTC neurotechnology regulated (in the US)?
Lumos Labs, Jungle Rangers,
UltimaEyes (2015-2016)
tDCS Home Device Kit (2013)

43. Is current regulatory oversight sufficient?
• DTC neurotech – device version of dietary supplements (?)

44. Is current regulatory oversight sufficient?
• DTC neurotech – device version of dietary supplements (?)
• DSHEA (1994): mostly post-market authority

45. 1. Effectiveness
• Does DTC neurotechnology work as advertised?

46. 1. Effectiveness
• Does DTC neurotechnology work as advertised?
• Lack of data
• Lack of data when translating from lab  consumer space
• Lack of scientific consensus (even with data)

47. 2. Consumer understanding
Consumer challenges in navigating claims

48. 2. Consumer understanding
Consumer challenges in navigating claims
• 21% of respondents in SharpBrains (2018) reported that ”navigating claims” was the
most important issue facing the brain fitness field

49. 2. Consumer understanding
Consumer challenges in navigating claims
• 21% of respondents in SharpBrains (2018) reported that ”navigating claims” was the
most important issue facing the brain fitness field
• AARP report: over a quarter of adults age 40 and older believe that the best way to
maintain/improve brain health is to play brain games, even though there is “little
scientific evidence” to support this (Mehegan et. al, 2017)

50. 3. Potential harms & ethical issues
• Safety
• 3% of users of neurostimulation devices reported serious skin burns (Wexler 2018)
• Unknown effects of chronic use: users stimulate far more frequently than scientists

51. 3. Potential harms & ethical issues
• Safety
• 3% of users of neurostimulation devices reported serious skin burns (Wexler 2018)
• Unknown effects of chronic use: users stimulate far more frequently than scientists
• Psychological Harm
• Unreliable (potentially false) information may cause individuals undue stress (Wexler &
Thibault, 2018)

52. 3. Potential harms & ethical issues
• Safety
• 3% of users of neurostimulation devices reported serious skin burns (Wexler 2018)
• Unknown effects of chronic use: users stimulate far more frequently than scientists
• Psychological Harm
• Unreliable (potentially false) information may cause individuals undue stress (Wexler &
Thibault, 2018)
• Additional considerations
• Opportunity costs
• May hold particular appeal for vulnerable populations
• Clear terms of service + data privacy policies

53. THE CHALLENGE
How do we foster innovation while ensuring adequate oversight?

54. What should we do?
• Independent working group
• Evaluate the main domains of
neurotechnology & provide appraisals of
potential harm and probable efficacy
• Disseminate information to key consumer
groups (e.g., AARP), media outlets, etc.
• Identify areas for future research
• Serve as a clearinghouse for regulatory
agencies, third-party organizations that
monitor advertising claims, industry, funding
agencies
Wexler & Reiner 2019

55. THANK YOU!
awex@pennmedicine.upenn.edu
Mehegan, L., Rainville, C., Skufca, L.“2017 AARP Cognitive Activity and Brain Health Survey” (AARP Research, Washington, DC, 2017),
doi:10.26419/res.00044.001.
SharpBrains, Market Report on Pervasive Neurotechnology: A Groundbreaking Analysis of 10,000+ Patent Filings Transforming Medicine,
Health, Entertainment and Business (2018) (available at https://sharpbrains.com/pervasive-neurotechnology/).
Wexler, A. & Thibault, R. (2018). Mind-reading or misleading? Assessing direct-to-consumer electroencephalography (EEG) devices marketed
for wellness and their ethical and regulatory implications. Journal of Cognitive Enhancement [published online first, Sep 2018].
Wexler, A. (2018). “Who uses direct-to-consumer brain stimulation products, and why? A study of home users of tDCS devices.” Journal of
Cognitive Enhancement, 2(1): 114-134.
Wexler A, & Reiner P.B. (2019). “Oversight of direct-to-consumer neurotechnologies.” Science, 363(6424):234-325.

56. May 2019

57. Akili is a leader in prescription
digital therapeutics by creating
video game treatments and
supportive technology applications for
cognitive dysfunction.
Building new treatment model rooted
in unique delivery, accessibility and
user experience — one that
traditional medicine and digital models
have yet to realize.
It’s time to play your
medicine.

58. Akili is a leader in prescription
digital therapeutics by creating
video game treatments and
supportive technology applications for
cognitive dysfunction.
Building new treatment model rooted
in unique delivery, accessibility and
user experience — one that
traditional medicine and digital models
have yet to realize.
It’s time to play your
medicine.

59. • Beyond behavioral therapy to physiologically-
active digital treatments
• Products and platform validated with rigorous
prospective pharma-style clinical trials
• Deep investment in user experience and
entertainment value
• First internally-operated, fully-integrated
business model
Evolving the definition of
Digital Therapeutics
‘Digital therapeutics represent a potential paradigm
shift in the way disease is treated, as software itself
starts to become the therapeutic…’
CowenResearch, 2018

60. Video game developers, artists and
influencers
LucasArts - Google - Microsoft
T E C H N O L O G Y &
G A M I N G
P H A R M A &
H E A L T H C A R E
Pharmaceutical leaders with deep
experience in novel commercial
launches
Shire - Sanofi - Pfizer
C L I N I C A L &
S C I E N C E
Best-in-class teams committed to R&D
and clinical trial development
MIT - Yale - Duke
BOSTON
SAN FRANCISCO
99
Diversity of perspective
is at the core of Akili’s
capabilities.

61. Unmet needs in
treating cognitive
dysfunction have
remained the same
for decades…

62. A D H D D E P R E S S I O N
M U L T I P L E
S C L E R O S I S
Center for Disease Control and Prevention; Anxiety and Depression Association of America; Multiple Sclerosis Discovery Forum; Data on File
Experience adverse
effects from drugs
67%
Show no response
to first drug therapy
50%
Have untreated cognitive
impairments that continue to
impact quality of life after
drug treatment
50%
children and adolescents in U.S. Americans treated every year diagnosed per week
6.5 million 12 million 200 new cases

63. • In-person therapy or Rx
pickup
• Treating symptoms
through non-specific
pharmacology
• SEs as a necessary
risk
• One size/type fits all
• Little data to understand
disease progress
• Targeting specific physiological
networks to treat specific functions
• Safe risk profile with no
AEs
• Adaptive, personalized technology
• Rich, continuous data to
visualize benefits & gain
insight
Akili’s Unique Approach to Treatment
TRADITIONAL MEDICINE
DRUGS & BEHAVIORAL THERAPY
DIGITAL TREATMENT
• Digital prescription
delivery

64. We believe medicine can be beautiful,
wonderful, captivating.
We believe medicine can be beautiful,
wonderful, captivating.

65. We believe medicine can be beautiful,
wonderful, captivating.
We believe medicine can be beautiful,
wonderful, captivating.

66. Privacy, Ethics and Regulatory Issues
Overcoming patient and societal fears
• Privacy
• Patient fears regarding privacy and security of sensitive diagnostic &
treatment information
• Loss of public trust in company transparency regarding use of data
• Informed consent
• Patient authentication and data integrity
• Patchwork of national/state/federal privacy laws
• Safety & Efficacy
• Suspicion regarding marketing claims versus approved medical
claims backed up by clinical trials
We’re interacting with patients in a new way.
Building trust is critical in everything we do.

68. Access recorded talks, Q&A, and more at:
SharpBrains.com