Patient Empowerment: �Entrusting data ownership to patients for RWE/RWD Access

Confidential -

All Rights Reserved. May 2023

Sundeep Gaba, CEO�AllesHealth

Introduction

• Evidence Based Healthcare Practitioner and Healthcare Technologist, with over 14 years in the industry, worked across 3 continents.
• Spent over 18 years in different industries including Banking, Oil & Gas and Healthcare.
• Held Global and Regional Leadership roles within Commercial and Technology functions at Roche.
• Studied - Evidence Based Health Care (EBHC) and Translational Health Sciences - University of Oxford, UK
• MBA, International Management - University of Wales, Cardiff.
• CEO and Founder of AllesHealth (a HealthTech company based in Basel, Switzerland)
• Passionate about Patient Engagement in the Digital Healthcare Ecosystem.

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Striving to find solutions for patients through Social HealthTech

AllesHealth

• A Basel, Switzerland based HealthTech company
• Focussing on Data Diversification challenges, initially from Low-Mid Income countries and Rare diseases.
• Clinical insights company focussed on connecting large structured datasets (RWD and RWE) from patients & carers with industry consumers like Practitioners, Healthcare Companies, Insurers and CRO's for overall improvement of Patient Health Management.
• Focussing on Patient Empowerment.
• Empowers patients by giving more health insights and control to patients and carers
• Reward mechanism that rewards Patients
• Compliant to global and local standards.

Patients and Carers as consumer of Health Services and owners of Health Data

Hospitals and Clinics

Healthcare Companies /CROs /Other SHs

AllesHealth Solutions

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AllesHealth ‘RealWorldEase’ (B2B) FOR

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Confidential - All Rights Reserved

Healthcare Companies Insurance Companies CROs

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Hospitals / Clinics HealthTech Companies

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AllesHealth�(B2C) FOR

Patients Carers

Embracing Change

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While AI may not replace clinicians, Patients will readily discard clinicians who fail to leverage technology for enhanced engagement.

Real World Data is more that just EHR/EMR….

Real World Data (RWD) is data collected from real-world sources, such as healthcare institutions, electronic health records (EHRs), claims databases, disease registries, wearable devices, patient surveys, and other sources outside of controlled clinical trials. RWD provides insights into real-world patient characteristics, treatment patterns, outcomes, and healthcare utilization.

Insights generated from RWD has the potential to provide better disease prediction, prevention and overall better disease management for Patients

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It allows individuals to actively participate in clinical research by sharing their health information, enabling every person to contribute to the generation of valuable insights.

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Biggest challenges to achieve promise of Personalised and Precision Medicine

Privacy and Data Security

Ethical and Legal Considerations

Data Quality and Standardization

Cost and Reimburse-ment

Data Integration and Interoperability

Overcoming these challenges requires collaboration among researchers, clinicians, policymakers, technology providers, and patients.

Lack of patients engagement and empowerment results in an inferior healthcare system

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65% of Black People have experienced prejudice from healthcare staff, rising to 75% for 18-34 year olds Black people

The move towards Digital Health Technologies is excluding some older adults, only 33% of 55-74 years

~78-88% of the genomics database is European, driving inequalities in Genomic led drug development

60% of global population is Asian, only 11% of global trial participants are Asian, with 76% white*

80% of clinical trials fail to meet enrollment timelines

Historic exploitation continues to impact trust in trial operators. Willingness to participate in trials has dropped below 50%

Data sources in speaker notes section

Patient Data and Engagement in �complete spectrum

Needs and Benefits

Regulations

Ownership and �Willingness to Share

Value

Ethics

Patients and Carers Lacking Clinical Insights & �Ownership of their Health Data causing poor patient engagement and high healthcare cost

Patients and caregivers worldwide lack access*

to their health data. This prevents them from making informed decisions about their health and participating in clinical research.

Lack of transparency to Health records

34%

reported

some access to their Health records

Confidential - All Rights Reserved

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Poor patient engagement

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High healthcare �cost

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Problems / issues of Healthcare system

*Commonwealth Fund International Health Policy Survey

Confidential - All Rights Reserved

Challenges to access RWE / RWD

Legal & Regulatory

• Issue with Data ownership and accessibility
• Different requirements between countries

Technical

• Databases that were not designed for research and incomplete or siloed data
• High data-input burden for HCPs

Cost & Acceptability

• Assumptions that data is biased
• Resistance to change
• High cost of Clinical insights Acquisition

Clinical Insights procurement

Multi billions $$ spend for Patient recruitment and

generating RWE & RWD every year

generating RWE and RWD

B

CROs

Life-Science Companies

B

Multi billions $$ spend in procurement of Clinical Insights for PHC research every year.

Lack of Data Diversification and �Lack of Access to RWE & RWD is choking Clinical Research

Patient Data and Engagement

in complete spectrum

Need and Benefits

Regulations

Ownership and �Willingness to Share

Value

Ethics

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Who Owns Patient Data?

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• Ownership of health data is a complex issue with no clear answer. Patients, healthcare providers, and technology companies may all have ownership rights to it.
• Patients have the right to control and manage their health data, including access, sharing, and deletion, to be informed and empowered.

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Willingness to share Health Data �for Clinical Research 2014 vs 2020

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Pre Covid Results

Post Covid Results

Patient Data in complete spectrum

Need and Benefits

Regulations

Ownership and �Willingness to Share

Value

Ethics

What Does The Regulations Say?

• Individuals are generally considered owners of their data under HIPAA, with the right to access, correct, and control their information.
• State laws, contracts, and other agreements may also play a role in health data ownership, but individuals have a fundamental right to control how their data is used and disclosed.

• Individuals own their health data according to the Swiss Federal Act on Data Protection (FADP), which gives them the right to control the use of their data and to grant or withhold consent for its processing.
• The FADP allows individuals to access their health data, and request corrections/deletions. The Swiss Federal Act on Health Insurance also regulates the use and disclosure of health data by insurance companies.

• Individuals in the EU own their health data under GDPR and have the right to control its processing. Health data is a special category of personal data, with additional protections.
• The GDPR allows individuals to access, correct, and delete their health data, giving them control over its use.

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• The Personal Data Protection Bill, 2019 proposes that individuals in India control their personal data, including health data.

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• The bill would give individuals the right to access, correct, restrict, object to processing, and request the erasure of their data, with additional safeguards for sensitive data like health information. While not yet enacted, the bill reflects the government's stance on privacy and data protection.

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Patient Data and Engagement �in complete spectrum

Need and Benefits

Regulations

Ownership and �Willingness to Share

Value & Rewards

Ethics

Creating patient confidence

Involve and engage at every step of the way

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Wheel of Patient Empowerment

• Patients need more transparency
• Patients want to get more educated about their health & get more involved in disease management
• Patients deserve higher value proposition
• As owners, Patients should feel secured and in control of their Health Data

Multi Stakeholder Approach

Benefits of RWE for Patients & Carers

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Preventive & Predictive Care

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1. Improved treatment decisions
2. Better understanding of disease
3. Personalized medicine
4. Better Patient engagement
5. Disease monitoring
6. Clinical Trial Participation

Patient & Carer

Rewarding patients with Health Rewards

Especially in ‘Out of Pocket’ and ‘Low-Insurance coverage’ models

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Choice of Health rewards that works for better Patient Engagement

Multi Stakeholder Approach

Benefits of RWE for CROs, Healthcare Companies, Insurance companies

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1. Clinical trial design and execution
2. Drug development and approval
3. Market access and pricing
4. Post-marketing surveillance and safety monitoring
5. Disease surveillance and management
6. Patient engagement and education

Healthcare Companies

Easier access for Research Data

1. Protocol design
2. Patient recruitment
3. Comparative effectiveness research
4. Post-marketing surveillance
5. Health economics and outcomes research
6. Support Regulatory Submissions

CROs

Support in Patient Recruitment

1. Risk assessment
2. Underwriting
3. Claims management
4. Product development
5. Fraud detection
6. Patient engagement

Insurance Companies

Better suited insurance products

Multi stakeholder Approach

Benefits of RWE for Hospitals / Clinics and Government organizations

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Efficient Hospital Management & Better Care

1. Quality improvement
2. Resource allocation
3. Patient safety
4. Population health management
5. Clinical decision-making
6. Research and innovation

Hospitals and �Clinics

1. Health policy development
2. Public health surveillance
3. Resource allocation
4. Comparative effectiveness research
5. Post-marketing surveillance
6. Regulatory decision-making

Government Organization

Better Policies and �Care Options

Benefits to providers in rewarding patients with Health Rewards

Especially in ‘Out of Pocket’ and ‘Low-Insurance coverage’ models

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• Increase patient intake by 50% through offering regular health check-up
• Targeted treatment based speciality (Gyn, Cardio, Onco etc.) reducing marketing cost
• Target towards digitally native population
• Increase Trust among patients and carers

For Hospitals & Clinics

• Direct offering to Patients (reducing reference distribution cost)
• Increased lab profitability by up to 50%
• Managing relationships for future Clinical testing needs
• Reducing overall Healthcare cost for Patients

For Labs

• Direct offerings to patients
• Targeted rewards to ensure Health Living
• Focus on keeping people out of Hospitals and live healthier
• Reducing overall Healthcare cost for Patients and Healthcare ecosystem

For Insurance Companies

Patient Generated Health Data and

Rewarding Patients for Health Data

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©Christine Jacob, Steven Bourke, Sabina Heuss. Originally published in JMIR Human Factors (https://humanfactors.jmir.org), 06.10.2022.

Patient Data and Engagement

in complete spectrum

Need and Benefits

Regulations

Ownership and �Willingness to Share

Value and Rewards

Ethics

Is it ethical to share Anonymised �Patient Health Data?

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• Advanced Medical Research
• Public Interest and Collective Benefit
• Informed consent within Legal Framework

- Privacy concerns

- Consent and control

- Security and Data breaches

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Data As A Choke Point

• Data is a choke point refers to the idea that access to data has become a critical bottleneck in many industries, including healthcare.
• Without access to the right data, stakeholders like healthcare providers, researchers, and policymakers may be limited in their ability to make informed decisions and drive innovation in the healthcare industry.

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Reward system has the potential �to foster the emergence of a circular economy

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Patient enabled with RWE / RWD

Hospitals and Clinics consuming RWE in exchange of offering Health rewards

Healthcare Companies /CROs /Other SHs consuming RWE in exchange for Rewards

Federated Data Governance approach

Big and Small leveraging AI to assess Electronic Medical Records

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AllesHealth Solutions

2

AllesHealth ‘RealWorldEase’ (B2B) FOR

​

Confidential - All Rights Reserved

Healthcare Companies Insurance Companies CROs

​

Hospitals / Clinics HealthTech Companies

1

AllesHealth�(B2C) FOR

Patients Carers

Patient Data and Engagement in �complete spectrum

Needs and Benefits

Regulations

Ownership and �Willingness to Share

Value

Ethics

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Semmelweis Moment

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• Giving birth on the right side

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• Priest route change

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• Ditch the bell

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• Wash hands!!!

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Join the mission to

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HELP 50M PATIENTS & CARERS BY 2027

Sundeep Gaba

Founder & CEO

+41 7986 58316 (CH) / +91 82644 58316 (IN)

Basel, Switzerland / Chandigarh, India sg@alleshealth.com; info@alleshealth.com https://alleshealth.com

Empowering Patients & Carers to achieve endless possibilities in Healthcare

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Confidential - All Rights Reserved

Appendix

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References

1. A study published in the Journal of Medical Internet Research found that 91% of survey respondents were willing to share their health data for research purposes if it could potentially benefit others. (Kass, N. E., et al. "Public Views on the Use of Health Data for Research." Journal of Medical Internet Research, vol. 18, no. 4, 2016, e114. doi:10.2196/jmir.5356)
2. A survey conducted by Rock Health found that 79% of respondents were willing to share their health data with researchers if it could improve healthcare outcomes. (Rock Health. "Consumer Attitudes Toward Data Sharing and Privacy." 2014, https://rockhealth.com/reports/consumer-attitudes-toward-data-sharing-and-privacy/)
3. A survey conducted by the Pew Research Center found that 56% of respondents were willing to share their health data for medical research purposes, while 24% were not willing and 19% were unsure. (Pew Research Center. "Americans' Attitudes About Medical Privacy." 2014, https://www.pewresearch.org/science/2014/05/20/americans-attitudes-about-medical-privacy/)
4. A survey conducted by the Pew Research Center found that 60% of US adults were willing to share their health data for medical research purposes, while 35% were not willing and 4% were unsure. (Pew Research Center. "Americans' Attitudes About Medical Privacy." 2020, https://www.pewresearch.org/science/2020/01/30/americans-attitudes-about-medical-privacy/)
5. A survey conducted by YouGov in the UK found that 61% of respondents were willing to share their health data with researchers if it could help improve treatments for diseases like cancer or dementia. (YouGov. "Research Reveals Brits' Attitudes Towards Health Data and Its Use." 2017, https://yougov.co.uk/topics/health/articles-reports/2017/06/23/research-reveals-brits-attitudes-towards-health-dat)
6. A survey conducted by Data for Policy in the UK found that 63% of respondents were willing to share their health data for research purposes if it could help improve healthcare services or public health. (Data for Policy. "Public Attitudes to Health Data Sharing." 2020, https://www.dataforpolicy.org/public-attitudes-to-health-data-sharing/)
7. A 2020 survey by Rock Health found that 84% of respondents in the United States were willing to share their health data for research purposes, but only 31% were willing to share it with technology companies. Reference: https://rockhealth.com/reports/navigating-the-promise-of-healthcare-ai/
8. A 2020 survey by KPMG found that 86% of healthcare professionals believed that patients should own their health data, and 80% of patients agreed. However, only 65% of patients were willing to share their health data with their healthcare provider. Reference: https://assets.kpmg/content/dam/kpmg/us/pdf/2020/06/healthcare-consumer-research-june-2020.pdf

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References

Data Ownership

EU: Article 4(1) of the General Data Protection Regulation (GDPR). European Data Protection Board (EDPB) Guidelines on the processing of personal data concerning health, available at: https://edpb.europa.eu/sites/edpb/files/files/file1/edpb_guidelines_202005_healthdata_covid19_en.pdf

India: In India, ownership of health data is not explicitly addressed in any specific law or regulation. However, the Personal Data Protection Bill, 2019, which is currently under consideration by the Indian Parliament, proposes that individuals should have the right to control their personal data, including health data. Personal Data Protection Bill, 2019 (Bill No. 373 of 2019), available at: http://164.100.47.4/BillsTexts/LSBillTexts/Asintroduced/373_2019_LS_Eng.pdf

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