Overview

Digital health companies are compelled to adapt to an increasing number of privacy regulations imposed by governments to protect consumers. This first-of-its-kind Summit provides digital health companies detailed and practical information on current regulatory requirements and on how to incorporate privacy by design into their development and commercialization efforts.

Target Audience

  • R&D, Engineering, Compliance, IT, Regulatory, Risk Management, Marketing, Quality Assurance and other staff at digital health companies (medical devices, IoMTs, wearables)
  • Law firms and consulting firms
  • Government officials
  • Industry associations
  • Financiers

Gold Sponsor

CyberActa, Inc.

Summit Chairpersons

John Giantsidis, JD, M.Eng., President, CyberActa, Inc.
Naeem Hashmi, Digital Health Solutions, Strategic Advisor, Boston Scientific

Current Speakers

Elena Ames, CIMP, CDPSE, Data Privacy Officer, BrightInsight
Barry P Chaiken, MD, Author, Navigating the Code: How Revolutionary Technology Transforms the Patient-Physician Journey
William Gamble, GDPR Consultant, IT Governance USA Ltd.
Reece Hirsch, Partner, Morgan Lewis & Bockius LLP
James P. Keller, Jr., MS, AAMIF, FACCE, Business Development Director, Medical Devices, BrightInsight
Jeffrey Moore, Chief Product Security Officer, Draeger Medical
Sam Riley, Senior Corporate Counsel, Dascena
Parthiv Shah, Senior Manager, Cybersecurity Services – Consulting, Cerner Corporation
Additional Speakers To Be Announced

Current Presentations

DIGITAL HEALTH PRIVACY: GROWING COMPLEXITY

This presentation will review the complex web of privacy laws applicable to medical devices, the Internet of Medical Things, and wearable devices. Using practical hypotheticals, the session will explore when these digital health products are subject to HIPAA, FTC privacy principles and the California Consumer Privacy Act. The presentation will also cover best practices for developing a privacy policy and privacy compliance program consistent with applicable laws and best practices.

Reece Hirsch, Partner, Morgan Lewis & Bockius LLP

OVERVIEW OF GDPR AND FUTURE EU LEGISLATION

  • Contrast GDPR with HIPAA
      6 principles and 3 rights
  • Future EU legislation
      Digital Marketing Act
      Digital Services Act
      Digital Governance Act
      Privacy
      AI
      De Identification issues
  • Issues with GDPR
      Handling healthcare (sensitive) information
      Transfers outside of EU (Article 44 post Schrems II)
      Privacy by design and default (Article 25 medical device software)
  • Staying out of trouble
      Good cyber security
      Privacy Policy
      Subject access request

William Gamble, GDPR Consultant, IT Governance USA Ltd.

DIGITAL HEALTH APPS AND SOFTWARE AS A MEDICAL DEVICE (SAMD) – INCORPORATING PRIVACY ENGINEERING IN YOUR ENGINEERING PRACTICES

John Giantsidis, JD, M.Eng., President, CyberActa, Inc.

MANAGING PRIVACY FOR SAMD PRODUCTS ON THE CLOUD

  1. Introduction
  2. Definition of SaMD
    • Compliance considerations – Regulatory, Quality, Security, and Privacy
    • The challenges of global SaMD deployment from a Regulatory, Quality, Security, and Privacy perspective
  3. Use case examples for SaMD products on the cloud
  4. Typical flow of PII and PHI in SaMD products on the cloud
  5. Examples of data breaches/vulnerabilities
    • Implications of data breaches/vulnerabilities – using examples from media of data breach fines or from regulatory bodies regarding potential fines
  6. Practical measures for managing privacy for SaMD products on the cloud
    • Defining privacy-by-design and commentary on the overall privacy framework for SaMD products on the cloud
    • Privacy considerations for SaMD architectural design
    • Operationalizing privacy for SaMD
  7. Wrap-up/summary
  8. Discussion/Q&A

Elena Ames, CIMP, CDPSE, Data Privacy Officer, BrightInsight
James P. Keller, Jr., MS, AAMIF, FACCE, Business Development Director, Medical Devices, BrightInsight

Topics to be Covered

  • Privacy Tsunami
    1. Privacy Regulation
    2. Differentiating Security and Privacy
    3. Translating Privacy Regulation in IT processes
    4. Privacy in Healthcare vs Consumer Health

  • Privacy by Design
    1. Privacy Implementation Frameworks
    2. Roadmap to implement Privacy
    3. Mapping Privacy obligation with IT processes
    4. Consent Design Strategies
    5. Privacy Enabling Technologies
    6. Privacy and Data Management

  • Embedding Privacy in Digital Health – Wearable, IoMTs, Medical Devices
    1. Privacy in Mobile Solutions
    2. Privacy in AI
    3. Privacy in the Cloud
    4. Privacy and Patient Monitoring
    5. Privacy and Tele-care
    6. Privacy Operationalization
     

For additional information, including speaking and sponsorship opportunities, please contact:

Satish Kavirajan, Managing Director, Actionable Intelligence Network
Email: sk@ain.events Tel: 310-995-6889

About the Summit Organizer

Through intensive market research, Actionable Intelligence Network (AIN) develops educational events that offer actionable information and insights and first-rate networking opportunities to our target audience. Our events are opportunities for executives to learn from their peers as well as leading consultants and innovative technology solution providers. We create events that help executives and clinicians to navigate technological change, offering practical solutions to pressing problems. The management of AIN has over 25 years of experience organizing healthcare, technology and finance conferences and exhibitions. For more information on AIN, please visit: ain.events