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How to address privacy, ethical and regulatory
issues: Examples in cognitive enhancement,
depression and ADHD
Chaired by: ...
.
Rethinkingandretooling
brainhealthwithethics
Karen S. Rommelfanger, PhD
Neuroethics Program Director,Center for Ethics
D...
Neuroethics:
• The societal, ethical and legal implications of neuroscience.
• An exploration of how neuroscience reflects...
.
.
.
.
Brain as Self: Roskies, 2007; Racine et al, 2010; De Jong et al, 2015 Kasulis in Swanson Brain Science and Kokoro, 2011;...
.
Brain as Self: Roskies, 2007; Racine et al, 2010; De Jong et al, 2015 Kasulis in Swanson Brain Science and Kokoro, 2011;...
.
• Societal Implications for
Brain as Self: Roskies, 2007; Racine et al, 2010; De Jong et al, 2015 Kasulis in Swanson Bra...
.
• Neuroethical concerns have risen to the
highest levels of government. (GNS
delegates, 2018)
• Values and culture deter...
future of healthcare early detection
early intervention disease modification.
Torous, 2016
Kirby et al, 2018
.
DATA
Detect 
Intervene 
Scale
• Continuous recording
• Surveillance:
Stigma
• Privacy,
• Treatment:
• Big Data Analytics:
• Bias
• Ownership and gatekee...
.
Privacy and re-identifiability
• Opportunity: continuous (vs. episodic), ubiquitous recording
• Risks:
re-identifiability
• Medicalization: Social process where
• Reinforcing bias: Groups and group differences are usually
defined by criteria th...
• Opportunity: Surveillance, Risk Assessment and Intervention
• Risks: New unanticipated/legacy use
• Beyond the clinic mi...
• Opportunity: Surveillance, Risk Assessment and Intervention
• Risks: New unanticipated/legacy use
• Beyond the clinic mi...
ew kinds of data.
• The purpose of big data analytics is to create new
unanticipated knowledge of already existing data
• ...
Issues unique ?
Not entirely
Yes
• Informed consent
?
• In US,
• In EU
• China
Japan
• It would be incorrect to suggest there are absolute differences, however relative
diffe...
70% of the worlds populations are collectivist.
Hofstede, 2014, Wu et al, 2015; Lan, 2015
Would you use enhancers?
Society...
trust respect
process
empower participants
Thankyou.
Karen Rommelfanger, PhD
krommel@emory.edu
Resources
OVERSIGHT OF DIRECT-
TO-CONSUMER
NEUROTECHNOLOGIES
Anna Wexler
SharpBrains Virtual Summit
May 7, 2019
Talk outline
• What is direct-to-consumer (DTC) neurotechnology?
• How is DTC neurotechnology regulated in the United Stat...
What is direct-to-consumer neurotechnology?
• the set of products (devices, software, applications) that are marketed to
m...
• Not referring to:
• Cognitive enhancement drugs
• Neuromarketing
• Invasive/implantable technologies (i.e., brain-comput...
Consumer neuroscience
technology market is predicted
to top $3 billion by 2020
(SharpBrains 2018)
How is DTC neurotechnology regulated (in the US)?
How is DTC neurotechnology regulated (in the US)?
According to Section 201(h) of the Food, Drug & Cosmetic (FD&C) Act, a
m...
How is DTC neurotechnology regulated (in the US)?
Any app/device/product that claims to diagnose or
treat disease is regul...
How is DTC neurotechnology regulated (in the US)?
21st Century Cures Act excludes from the definition of a
medical device ...
How is DTC neurotechnology regulated (in the US)?
FDA will exercise enforcement discretion for low-risk
devices marketed f...
How is DTC neurotechnology regulated (in the US)?
FDA will exercise enforcement discretion for low-risk
devices marketed f...
How is DTC neurotechnology regulated (in the US)?
Lumos Labs, Jungle Rangers,
UltimaEyes (2015-2016)
How is DTC neurotechnology regulated (in the US)?
Lumos Labs, Jungle Rangers,
UltimaEyes (2015-2016)
tDCS Home Device Kit ...
Is current regulatory oversight sufficient?
• DTC neurotech – device version of dietary supplements (?)
Is current regulatory oversight sufficient?
• DTC neurotech – device version of dietary supplements (?)
• DSHEA (1994): mo...
1. Effectiveness
• Does DTC neurotechnology work as advertised?
1. Effectiveness
• Does DTC neurotechnology work as advertised?
• Lack of data
• Lack of data when translating from lab  ...
2. Consumer understanding
Consumer challenges in navigating claims
2. Consumer understanding
Consumer challenges in navigating claims
• 21% of respondents in SharpBrains (2018) reported tha...
2. Consumer understanding
Consumer challenges in navigating claims
• 21% of respondents in SharpBrains (2018) reported tha...
3. Potential harms & ethical issues
• Safety
• 3% of users of neurostimulation devices reported serious skin burns (Wexler...
3. Potential harms & ethical issues
• Safety
• 3% of users of neurostimulation devices reported serious skin burns (Wexler...
3. Potential harms & ethical issues
• Safety
• 3% of users of neurostimulation devices reported serious skin burns (Wexler...
THE CHALLENGE
How do we foster innovation while ensuring adequate oversight?
What should we do?
• Independent working group
• Evaluate the main domains of
neurotechnology & provide appraisals of
pote...
THANK YOU!
awex@pennmedicine.upenn.edu
Mehegan, L., Rainville, C., Skufca, L.“2017 AARP Cognitive Activity and Brain Healt...
May 2019
Akili is a leader in prescription
digital therapeutics by creating
video game treatments and
supportive technology applica...
Akili is a leader in prescription
digital therapeutics by creating
video game treatments and
supportive technology applica...
• Beyond behavioral therapy to physiologically-
active digital treatments
• Products and platform validated with rigorous
...
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 ...
Unmet needs in
treating cognitive
dysfunction have
remained the same
for decades…
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 Depre...
• In-person therapy or Rx
pickup
• Treating symptoms
through non-specific
pharmacology
• SEs as a necessary
risk
• One siz...
We believe medicine can be beautiful,
wonderful, captivating.
We believe medicine can be beautiful,
wonderful, captivating.
We believe medicine can be beautiful,
wonderful, captivating.
We believe medicine can be beautiful,
wonderful, captivating.
Privacy, Ethics and Regulatory Issues
Overcoming patient and societal fears
• Privacy
• Patient fears regarding privacy an...
Access recorded talks, Q&A, and more at:
SharpBrains.com
How to address privacy, ethical and regulatory issues: Examples in cognitive enhancement, depression and ADHD
How to address privacy, ethical and regulatory issues: Examples in cognitive enhancement, depression and ADHD
How to address privacy, ethical and regulatory issues: Examples in cognitive enhancement, depression and ADHD
How to address privacy, ethical and regulatory issues: Examples in cognitive enhancement, depression and ADHD
How to address privacy, ethical and regulatory issues: Examples in cognitive enhancement, depression and ADHD
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How to address privacy, ethical and regulatory issues: Examples in cognitive enhancement, depression and ADHD

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/

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How to address privacy, ethical and regulatory issues: Examples in cognitive enhancement, depression and ADHD

  1. 1. 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
  2. 2. . Rethinkingandretooling brainhealthwithethics Karen S. Rommelfanger, PhD Neuroethics Program Director,Center for Ethics Departments of Neurology and Psychiatry & Behavioral Sciences
  3. 3. Neuroethics: • The societal, ethical and legal implications of neuroscience. • An exploration of how neuroscience reflects and informs our societal values.
  4. 4. .
  5. 5. .
  6. 6. .
  7. 7. . 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
  8. 8. . 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
  9. 9. . • 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
  10. 10. . • 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
  11. 11. future of healthcare early detection early intervention disease modification.
  12. 12. Torous, 2016 Kirby et al, 2018
  13. 13. . DATA Detect  Intervene  Scale
  14. 14. • 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
  15. 15. .
  16. 16. Privacy and re-identifiability • Opportunity: continuous (vs. episodic), ubiquitous recording • Risks: re-identifiability
  17. 17. • 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.
  18. 18. • 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?
  19. 19. • 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
  20. 20. 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
  21. 21. Issues unique ? Not entirely Yes • Informed consent
  22. 22. ? • 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
  23. 23. 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
  24. 24. trust respect process empower participants
  25. 25. Thankyou. Karen Rommelfanger, PhD krommel@emory.edu Resources
  26. 26. OVERSIGHT OF DIRECT- TO-CONSUMER NEUROTECHNOLOGIES Anna Wexler SharpBrains Virtual Summit May 7, 2019
  27. 27. 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?
  28. 28. 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
  29. 29. • Not referring to: • Cognitive enhancement drugs • Neuromarketing • Invasive/implantable technologies (i.e., brain-computer interfaces) • Very futuristic technologies What is direct-to-consumer neurotechnology?
  30. 30. Consumer neuroscience technology market is predicted to top $3 billion by 2020 (SharpBrains 2018)
  31. 31. How is DTC neurotechnology regulated (in the US)?
  32. 32. 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.
  33. 33. 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
  34. 34. 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”
  35. 35. 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
  36. 36. 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”
  37. 37. How is DTC neurotechnology regulated (in the US)? Lumos Labs, Jungle Rangers, UltimaEyes (2015-2016)
  38. 38. How is DTC neurotechnology regulated (in the US)? Lumos Labs, Jungle Rangers, UltimaEyes (2015-2016) tDCS Home Device Kit (2013)
  39. 39. Is current regulatory oversight sufficient? • DTC neurotech – device version of dietary supplements (?)
  40. 40. Is current regulatory oversight sufficient? • DTC neurotech – device version of dietary supplements (?) • DSHEA (1994): mostly post-market authority
  41. 41. 1. Effectiveness • Does DTC neurotechnology work as advertised?
  42. 42. 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)
  43. 43. 2. Consumer understanding Consumer challenges in navigating claims
  44. 44. 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
  45. 45. 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)
  46. 46. 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
  47. 47. 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)
  48. 48. 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
  49. 49. THE CHALLENGE How do we foster innovation while ensuring adequate oversight?
  50. 50. 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
  51. 51. 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.
  52. 52. May 2019
  53. 53. 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.
  54. 54. 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.
  55. 55. • 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
  56. 56. 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.
  57. 57. Unmet needs in treating cognitive dysfunction have remained the same for decades…
  58. 58. 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
  59. 59. • 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
  60. 60. We believe medicine can be beautiful, wonderful, captivating. We believe medicine can be beautiful, wonderful, captivating.
  61. 61. We believe medicine can be beautiful, wonderful, captivating. We believe medicine can be beautiful, wonderful, captivating.
  62. 62. 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.
  63. 63. Access recorded talks, Q&A, and more at: SharpBrains.com

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/

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