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www.humanbrainexpo.com
Online
Nov., 8
WEBINAR
Huma n Wellness in Digita l Spa ce
Rebecca Short, DO, MPH
Associate Medical Director
| Corte Madera & San Francisco Office
D ay 1 : D i g i ta l Psy c h i a t r y
OUR SPEAKERS:
Steven Reidbord, M.D.
Private office-based practice
Samee Shahzada, M.D.
Psychiatrist at Adventist Health
and Kaiser Permanente
1
www.humanbrainexpo.com
Online
Nov., 8
WEBINAR
Huma n Wellness in Digita l Spa ce
D ay 1 : D i g i ta l Psy c h i a t r y
The series of webinars dedicated to “Human Wellness in
Digital Space” was organized in the scope of the
promotional effort of the Human Brain Expo 2023.
GOAL is to create an innovative and interactive
interdisciplinary ecosystem to propagate the Brain
Health Treatments evolvement.
MISSION is to facilitate interdisciplinary collaborations
and knowledge exchange to improve industry standards
for brain health management and science of emotional
wellness.
2
D i g i t a l Psy c h i a t r y
M e n t a l H e a l t h i n t h e U S D a t a
3
Adult Prevalence of Mental Illness (AMI) 2022
19.86% of adults are experiencing a mental illness. Equivalent to nearly 50
Americans. 4.91% are experiencing a severe mental illness. The state prevalence
of adult mental illness ranges from 16.37% in New Jersey to 26.86% in Utah.
National Alliance on Mental Illness (NAMI) 2020
D i g i t a l Psy c h i a t r y
M e n t a l H e a l t h i n t h e Wo r l d
4
The McKinsey Health Institute conducted a global survey in 15 countries between February and April
2022. This survey involved nearly 15,000 employees in 15 countries: Argentina, Australia, Brazil,
China, Egypt, France, Germany, India, Japan, Mexico, South Africa, Switzerland, Turkey, the United
Kingdom, and the United States.
D i g i t a l Psy c h i a t r y
Q U E S T I O N 1
5
Q1: Please, comment. Agree/Disagree.
Are there any significant changes happened in
your practices?
How did you adjust your practices to the Covid-19
needs?
D i g i t a l Psy c h i a t r y
Q U E S T I O N 2
6
Psychiatric symptoms and psychiatric disorders are presented in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition and the International Classification of Diseases, 10th Revision.
Common symptoms and disorders include depression, alcohol use disorder , anxiety, insomnia, suicidality, autism, attention deficit hyperactivity disorder , obsessive compulsive, disorder, and post-traumatic stress disorder
FDA believes the policy will help address these urgent public health concerns by helping to expand the availability of digital
health therapeutic devices (as defined below) for psychiatric conditions. Device availability may increase patient access to
digital therapeutics while individuals are following “stay at home” orders or practicing social distancing, without the need for
in-clinic visits during the COVID-19 public health emergency. Furthermore, increased utilization of digital therapeutic devices
may ease burdens on hospitals and other healthcare facilities and reduce the risk of exposure to SARS-CoV-2 for patients and
health care providers.
Software functions that may meet the definition of a device but for which FDA does not intend to enforce requirements under the FD&C 1) General Wellness software functions to promote, track, and/or encourage choices,
which,
as part of a healthy lifestyle… 2) Software functions that help patients with diagnosed psychiatric conditions maintain their behavioral coping skills by providing a “Skill of the Day” behavioral technique or audio messages…
3) that the user can access when experiencing increased anxiety related to the COVID-19 public health emergency… 4) Software functions that display, at opportune times, images or other messages for a substance user
who wants to stop addictive behavior due to increased anxiety during the
COVID-19 public health emergency. 5) Software functions that help patients or users self-manage their disease or conditions
without providing specific treatment or treatment suggestions. 6) Software functions that use a checklist or a questionnaire of common signs and symptoms for a psychiatric disorder (e.g., anxiety due to stay-in-place orders)
and to provide a list of
possible medical conditions and advice on when to consult a health care provider. 7) Software functions that guide a user through a questionnaire of signs and symptoms for a psychiatric disorder (e.g., anxiety or stress due
to stay-in-place orders) and to provide a
recommendation for the type of health care facility most appropriate to their needs.
Q2: Do you prescribe /recommend any FDA -
cleared Digital Solutions?
D i g i t a l Psy c h i a t r y
Q U E S T I O N 3
9
While outside the FDA’s current scope, addressing privacy risks and degradation of trust in the digital health space
may be necessary to ensure the FDA’s vision for the development and regulation of safe and effective digital tools is
realized. New solutions like provider organization-specific digital formularies could help patients and clinicians
focus on safe and validated digital tools21, with some large healthcare organizations already embracing the concept
and creating their own ‘digital ecosystems’, such as Kaiser Permanete22 and the United States Veteran’s
Adminstration23. These digital formularies appear highly utilized22,23, even though they focus on apps that fall
beyond the scope of active FDA regulation.
A 2021 review of 20,911 apps in the medical and health and fitness categories in the Google play store found that
28% offered no privacy policies and 88% included code that could potentially collect user data19.
Torous J, Stern AD, Bourgeois FT. Regulatory considerations to keep pace with innovation in digital health products. NPJ
Digit Med. 2022 Aug 19;5(1):121. doi: 10.1038/s41746-022-00668-9. PMID: 35986056; PMCID: PMC9390099.
Q3: Comment. Do you implement extra steps to
provide security? Do you educate your patients?
D i g i t a l Psy c h i a t r y
Q U E S T I O N 4
10
Rigorously studying digital interventions will require addressing new considerations in study design, including digital placebo
effects, digital literacy, health equity, and the generalizability of studies to account for real-world implementation and use. For
example, studies that utilize a control group that does not also use technology often report large effect sizes, likely due to a
digital placebo effect11 Adding a digital placebo, a version of the same app that is missing the “active ingredient,” is an
underutilized approach that may help better identify effective apps10. For example, Novartis acquired the rights to an app
for schizophrenia that had completed two successful but uncontrolled pilot studies demonstrating initial efficacy for
improving symptoms. However, when Novartis tested a modified version of the app in a larger study that included a
digital placebo, they found no differences between the study arms12. Many digital health apps today are complex
multimodal interventions and identifying the active ingredient, let alone an appropriate control group remains
challenging. Still, identifying active ingredients and their mechanisms of action is important for designing studies
that can evaluate digital products.
Q4: How trustworthy the studies of the digital tools are?
Your perspective.
11
12
D i g i t a l Psy c h i a t r y
Q U E S T I O N 5
A worldwide programmatic movement has evolved to re‐humanize medicine and public health.
The epistemological definition of person‐centered medicine proposes a holistic and collaborative medicine that is informed by
evidence, experience and values, and aimed to health restauration and promotion of the whole person.
So, the person centered approach is emerging as a widely recognized and respected core feature of psychiatry and
medicine.
Okasha A. The "Meet the WPA Council" Panel at the 21st World Congress of Psychiatry. World Psychiatry. 2022
Jun;21(2):326-327. doi: 10.1002/wps.20957. PMID: 35524612; PMCID: PMC9077593.
Q5: Comment. How digital tools can
change/not change/influence this movement?
13
D i g i t a l Psy c h i a t r y
Q U E S T I O N 6
Threats to Global Mental Health From Unregulated Digital Phenotyping and Neuromarketing
Digital phenotyping is an especially attractive clinical tool for substance use treatment during the COVID-19 pandemic, as it not only
operates remotely but is also convenient for patients (no active input required), is not administratively burdensome, and may be an
effective way to address historic challenges in detecting problematic substance use behaviors and delivering timely clinical
interventions. Digital phenotyping has shown initial success in relapse prediction for schizophrenia [12], bipolar disorder [13,14], and
mood disorder detection [14]. We describe three broad applications of digital phenotyping for addiction treatment, highlighting their
potential clinical use, state of evidence, and next steps for implementation.
Hsu M, Ahern DK, Suzuki J
Digital Phenotyping to Enhance Substance Use Treatment During the
COVID-19 Pandemic
JMIR Ment Health 2020;7(10):e21814
doi: 10.2196/21814
Q6: Can Digital Phenotyping
Help in your practices?
Digital phenotyping aims to detect and categorize an individual's behavior, activities, interests, and
psychological features to properly customize future communications or mental care for that individual.
Neuromarketing seeks to investigate an individual's neuronal response(s) (cortical and subcortical autonomic)
characteristics and uses this data to direct the person into purchasing merchandise of interest, or shaping
individual's opinion in consumer, social or political decision making, etc.
14
GPS data have recently offered insights into the relationship between reduced mobility and poorer mental health during
the COVID-19 pandemic23. Passive data from smartphones have also been shown to correlate with outcomes such as
social functioning and loneliness24, 25. An important trend emerging from passive data studies in various conditions is that
variance, or measures of entropy or deviation from a personal mean, appear of more value than absolute measurements
from any sensors23-25.
Hariman, K., Ventriglio, A. & Bhugra, D. The Future of Digital Psychiatry. Curr Psychiatry Rep 21, 88 (2019).
https://doi.org/10.1007/s11920-019-1074-4
D i g i t a l Psy c h i a t r y
Q U E S T I O N 7
Q7: Did you notice any specific symptoms and/or
thoughts patterns, that associated with the
downside of Social Media Usage? How metaverse
can impact?

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Webinar_Nov8_Digital Psychiatry.pptx

  • 1. www.humanbrainexpo.com Online Nov., 8 WEBINAR Huma n Wellness in Digita l Spa ce Rebecca Short, DO, MPH Associate Medical Director | Corte Madera & San Francisco Office D ay 1 : D i g i ta l Psy c h i a t r y OUR SPEAKERS: Steven Reidbord, M.D. Private office-based practice Samee Shahzada, M.D. Psychiatrist at Adventist Health and Kaiser Permanente 1
  • 2. www.humanbrainexpo.com Online Nov., 8 WEBINAR Huma n Wellness in Digita l Spa ce D ay 1 : D i g i ta l Psy c h i a t r y The series of webinars dedicated to “Human Wellness in Digital Space” was organized in the scope of the promotional effort of the Human Brain Expo 2023. GOAL is to create an innovative and interactive interdisciplinary ecosystem to propagate the Brain Health Treatments evolvement. MISSION is to facilitate interdisciplinary collaborations and knowledge exchange to improve industry standards for brain health management and science of emotional wellness. 2
  • 3. D i g i t a l Psy c h i a t r y M e n t a l H e a l t h i n t h e U S D a t a 3 Adult Prevalence of Mental Illness (AMI) 2022 19.86% of adults are experiencing a mental illness. Equivalent to nearly 50 Americans. 4.91% are experiencing a severe mental illness. The state prevalence of adult mental illness ranges from 16.37% in New Jersey to 26.86% in Utah. National Alliance on Mental Illness (NAMI) 2020
  • 4. D i g i t a l Psy c h i a t r y M e n t a l H e a l t h i n t h e Wo r l d 4 The McKinsey Health Institute conducted a global survey in 15 countries between February and April 2022. This survey involved nearly 15,000 employees in 15 countries: Argentina, Australia, Brazil, China, Egypt, France, Germany, India, Japan, Mexico, South Africa, Switzerland, Turkey, the United Kingdom, and the United States.
  • 5. D i g i t a l Psy c h i a t r y Q U E S T I O N 1 5 Q1: Please, comment. Agree/Disagree. Are there any significant changes happened in your practices? How did you adjust your practices to the Covid-19 needs?
  • 6. D i g i t a l Psy c h i a t r y Q U E S T I O N 2 6 Psychiatric symptoms and psychiatric disorders are presented in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition and the International Classification of Diseases, 10th Revision. Common symptoms and disorders include depression, alcohol use disorder , anxiety, insomnia, suicidality, autism, attention deficit hyperactivity disorder , obsessive compulsive, disorder, and post-traumatic stress disorder FDA believes the policy will help address these urgent public health concerns by helping to expand the availability of digital health therapeutic devices (as defined below) for psychiatric conditions. Device availability may increase patient access to digital therapeutics while individuals are following “stay at home” orders or practicing social distancing, without the need for in-clinic visits during the COVID-19 public health emergency. Furthermore, increased utilization of digital therapeutic devices may ease burdens on hospitals and other healthcare facilities and reduce the risk of exposure to SARS-CoV-2 for patients and health care providers. Software functions that may meet the definition of a device but for which FDA does not intend to enforce requirements under the FD&C 1) General Wellness software functions to promote, track, and/or encourage choices, which, as part of a healthy lifestyle… 2) Software functions that help patients with diagnosed psychiatric conditions maintain their behavioral coping skills by providing a “Skill of the Day” behavioral technique or audio messages… 3) that the user can access when experiencing increased anxiety related to the COVID-19 public health emergency… 4) Software functions that display, at opportune times, images or other messages for a substance user who wants to stop addictive behavior due to increased anxiety during the COVID-19 public health emergency. 5) Software functions that help patients or users self-manage their disease or conditions without providing specific treatment or treatment suggestions. 6) Software functions that use a checklist or a questionnaire of common signs and symptoms for a psychiatric disorder (e.g., anxiety due to stay-in-place orders) and to provide a list of possible medical conditions and advice on when to consult a health care provider. 7) Software functions that guide a user through a questionnaire of signs and symptoms for a psychiatric disorder (e.g., anxiety or stress due to stay-in-place orders) and to provide a recommendation for the type of health care facility most appropriate to their needs. Q2: Do you prescribe /recommend any FDA - cleared Digital Solutions?
  • 7. D i g i t a l Psy c h i a t r y Q U E S T I O N 3 9 While outside the FDA’s current scope, addressing privacy risks and degradation of trust in the digital health space may be necessary to ensure the FDA’s vision for the development and regulation of safe and effective digital tools is realized. New solutions like provider organization-specific digital formularies could help patients and clinicians focus on safe and validated digital tools21, with some large healthcare organizations already embracing the concept and creating their own ‘digital ecosystems’, such as Kaiser Permanete22 and the United States Veteran’s Adminstration23. These digital formularies appear highly utilized22,23, even though they focus on apps that fall beyond the scope of active FDA regulation. A 2021 review of 20,911 apps in the medical and health and fitness categories in the Google play store found that 28% offered no privacy policies and 88% included code that could potentially collect user data19. Torous J, Stern AD, Bourgeois FT. Regulatory considerations to keep pace with innovation in digital health products. NPJ Digit Med. 2022 Aug 19;5(1):121. doi: 10.1038/s41746-022-00668-9. PMID: 35986056; PMCID: PMC9390099. Q3: Comment. Do you implement extra steps to provide security? Do you educate your patients?
  • 8. D i g i t a l Psy c h i a t r y Q U E S T I O N 4 10 Rigorously studying digital interventions will require addressing new considerations in study design, including digital placebo effects, digital literacy, health equity, and the generalizability of studies to account for real-world implementation and use. For example, studies that utilize a control group that does not also use technology often report large effect sizes, likely due to a digital placebo effect11 Adding a digital placebo, a version of the same app that is missing the “active ingredient,” is an underutilized approach that may help better identify effective apps10. For example, Novartis acquired the rights to an app for schizophrenia that had completed two successful but uncontrolled pilot studies demonstrating initial efficacy for improving symptoms. However, when Novartis tested a modified version of the app in a larger study that included a digital placebo, they found no differences between the study arms12. Many digital health apps today are complex multimodal interventions and identifying the active ingredient, let alone an appropriate control group remains challenging. Still, identifying active ingredients and their mechanisms of action is important for designing studies that can evaluate digital products. Q4: How trustworthy the studies of the digital tools are? Your perspective.
  • 9. 11
  • 10. 12 D i g i t a l Psy c h i a t r y Q U E S T I O N 5 A worldwide programmatic movement has evolved to re‐humanize medicine and public health. The epistemological definition of person‐centered medicine proposes a holistic and collaborative medicine that is informed by evidence, experience and values, and aimed to health restauration and promotion of the whole person. So, the person centered approach is emerging as a widely recognized and respected core feature of psychiatry and medicine. Okasha A. The "Meet the WPA Council" Panel at the 21st World Congress of Psychiatry. World Psychiatry. 2022 Jun;21(2):326-327. doi: 10.1002/wps.20957. PMID: 35524612; PMCID: PMC9077593. Q5: Comment. How digital tools can change/not change/influence this movement?
  • 11. 13 D i g i t a l Psy c h i a t r y Q U E S T I O N 6 Threats to Global Mental Health From Unregulated Digital Phenotyping and Neuromarketing Digital phenotyping is an especially attractive clinical tool for substance use treatment during the COVID-19 pandemic, as it not only operates remotely but is also convenient for patients (no active input required), is not administratively burdensome, and may be an effective way to address historic challenges in detecting problematic substance use behaviors and delivering timely clinical interventions. Digital phenotyping has shown initial success in relapse prediction for schizophrenia [12], bipolar disorder [13,14], and mood disorder detection [14]. We describe three broad applications of digital phenotyping for addiction treatment, highlighting their potential clinical use, state of evidence, and next steps for implementation. Hsu M, Ahern DK, Suzuki J Digital Phenotyping to Enhance Substance Use Treatment During the COVID-19 Pandemic JMIR Ment Health 2020;7(10):e21814 doi: 10.2196/21814 Q6: Can Digital Phenotyping Help in your practices? Digital phenotyping aims to detect and categorize an individual's behavior, activities, interests, and psychological features to properly customize future communications or mental care for that individual. Neuromarketing seeks to investigate an individual's neuronal response(s) (cortical and subcortical autonomic) characteristics and uses this data to direct the person into purchasing merchandise of interest, or shaping individual's opinion in consumer, social or political decision making, etc.
  • 12. 14 GPS data have recently offered insights into the relationship between reduced mobility and poorer mental health during the COVID-19 pandemic23. Passive data from smartphones have also been shown to correlate with outcomes such as social functioning and loneliness24, 25. An important trend emerging from passive data studies in various conditions is that variance, or measures of entropy or deviation from a personal mean, appear of more value than absolute measurements from any sensors23-25. Hariman, K., Ventriglio, A. & Bhugra, D. The Future of Digital Psychiatry. Curr Psychiatry Rep 21, 88 (2019). https://doi.org/10.1007/s11920-019-1074-4 D i g i t a l Psy c h i a t r y Q U E S T I O N 7 Q7: Did you notice any specific symptoms and/or thoughts patterns, that associated with the downside of Social Media Usage? How metaverse can impact?