Unedited LCD Supplement Ideas

Things you might think about "after" you have submitted an LCD request.

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From Chat GPT 4.0, June 2023.

The MolDx review process, being government-operated, is indeed challenging to accelerate due to its complex nature. However, there are several strategies your company AAA might consider in an attempt to expedite the process and draw attention to the potential benefits of your ZZZ type test:

Peer-reviewed publications and case studies: There's nothing quite as powerful as sound scientific evidence to validate a novel diagnostic approach. Encourage the team to conduct more research using the test and publish in reputable journals. This evidence will be instrumental in the review process.

Engagement with Professional Organizations: Align with professional societies that have a vested interest in diagnostic testing or the patient populations your test may benefit. These groups can assist in lobbying and provide significant support. Their endorsement or recognition can add credibility and visibility.

Patient Advocacy Groups: Work with patient advocacy groups who can bring attention to the need for expedited review. The voices of patients, particularly those who are immunocompromised and may directly benefit from faster diagnosis, can be very powerful.

Public Awareness Campaigns: Implement a campaign to inform the public about your test's benefits and the roadblocks you face. Use both traditional and social media to share stories of how your testing has helped patients and physicians. Encourage doctors and patients to share their own stories. Create a hashtag for your campaign and try to generate viral attention.

Healthcare Provider Endorsements: Having physicians who understand the benefits of the AAA test could help advocate for its approval. They can write opinion pieces in medical journals, speak at conferences, and reach out directly to their networks.

Engage with Key Opinion Leaders (KOLs): Partnering with KOLs can significantly raise the profile of your test. They can support your cause by talking about your product in scientific meetings and conferences.

Collaboration with other diagnostic companies: Form alliances with other diagnostic companies facing similar challenges to lobby for more streamlined review processes. There's strength in numbers and shared experiences.

Direct Communication: Maintain frequent and open lines of communication with MolDx to ensure they have all the necessary information and understand the importance and urgency of your request.

Economic Value Proposition: Show how the AAA test might save Medicare money in the long run. Compare the cost of doing the test with the costs associated with delayed diagnosis and treatment in BBB patients.

Remember, while these strategies can help draw attention and potentially expedite the review process, it's critical to adhere to all the guidelines and requirements set forth by the MolDx program. Patience and persistence will be key.

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What are pro's and con's of those tactics? One by one.

Sure, let's dive a bit deeper into each strategy, exploring their potential advantages and potential shortcomings:

1. Peer-reviewed publications and case studies

• Effective because:

• It provides robust scientific evidence for the effectiveness and reliability of the Karius test.
• It raises awareness within the medical community, which could lead to more support and endorsement.

• May be ineffective because:

• It takes a significant amount of time to conduct studies and get them published.
• Even once published, there's no guarantee that the right people at MolDx will see or be influenced by them.

2. Engagement with Professional Organizations

• Effective because:

• These organizations often have influential voices and extensive networks.
• They can lend credibility to your efforts and help lobby for a quicker review process.

• May be ineffective because:

• Some organizations might hesitate to get involved in lobbying for individual products.
• The process of getting the organizations on board can be time-consuming and doesn't guarantee success.

3. Patient Advocacy Groups

• Effective because:

• They can put a human face on the issue and generate public and political support.
• They are skilled in grassroots advocacy, which can garner significant attention.

• May be ineffective because:

• Some groups may have other priorities and may not choose to focus on your test.
• It might be challenging to mobilize patient groups quickly, which could delay the overall process.

4. Public Awareness Campaigns

• Effective because:

• It can raise broad public awareness and increase pressure on MolDx.
• Success stories from doctors and patients can be very persuasive.

• May be ineffective because:

• It can be costly and time-consuming to create and implement a successful campaign.
• There is a risk of backlash if the campaign is seen as pressuring a regulatory body.

5. Healthcare Provider Endorsements

• Effective because:

• Doctors are trusted figures, and their endorsements can be influential.
• They can share first-hand experiences of the benefits of your test, which can resonate with the MolDx team.

• May be ineffective because:

• Not all doctors may be willing to publicize their endorsement due to potential conflicts of interest.
• Physicians' opinions may not carry significant weight in a bureaucratic review process.

6. Engage with Key Opinion Leaders (KOLs)

• Effective because:

• KOLs have significant influence within the medical community and may sway the opinion of the MolDx team.
• They can speak about your product at scientific meetings and conferences, broadening its exposure.

• May be ineffective because:

• The KOL's audience may not include the decision-makers at MolDx.
• It might be challenging to get KOLs on board, especially if they perceive a conflict of interest.

7. Collaboration with other diagnostic companies

• Effective because:

• It creates a united front and amplifies the call for process efficiency.
• The shared experiences can provide a broader perspective on the problem and potential solutions.

• May be ineffective because:

• Other companies might see CLIENT as a competitor and be reluctant to collaborate.
• Different companies may have diverging priorities, making it hard to reach consensus on the best strategy.

8. Direct Communication

• Effective because:

• It ensures that MolDx has all the necessary information.
• It allows you to clarify any questions or concerns in real-time.

• May be ineffective because:

• MolDx might see this as overstepping boundaries or attempting to influence the process unduly.
• The MolDx staff may be too busy to maintain frequent communications.

9. Economic Value Proposition

• Effective because:

• It can appeal to MolDx's goal of cost-efficiency in healthcare.
• It presents the test as a long-term investment for better patient outcomes.

• May be ineffective because:

• The long-term cost savings may be difficult to quantify or prove convincingly.
• Economic arguments may not be compelling if MolDx prioritizes other factors like safety and efficacy.

Please note that these strategies should be used as a guide and may need to be adapted to the specific context and circumstances of your company and product. 

Unedited Summary of Webinar by AI - 20230629

 Unedited AI summary (GPT3.5) from typed bullet notes.  Not proofed or corrected.

20230629 - MolDx program and Z codes; hosted by Dark Daily; sponsored by Xifin.

https://www.discoveriesinhealthpolicy.com/2023/06/moldx-90-minute-webinar-on-z-codes-via.html

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Report on MolDx Medical Policy Webinar

The webinar, organized by DARK DAILY, provided valuable insights into the changing landscape of medical policies and reimbursement strategies. The speakers included industry experts from XIFIN, ARUP, MolDx, and executive Kyle Fetter. The meeting consisted of three informative segments followed by a panel discussion.

Segment 1: Overview of Payment Controls and Policies by Dr. GBW

Dr. GBW provided a comprehensive overview of the payment controls and policies implemented to address challenges faced by laboratories. The existing coding system often poses difficulties for payors to understand the services provided due to vague codes and lack of standardization. To tackle this, policies and payment controls were introduced to provide clarity. Dr. GBW emphasized the importance of explaining the services performed and their significance to payors, highlighting the need for clear codes and documentation. The MolDx program, initiated in 2011/2012, focuses on addressing these issues for Medicare while also benefiting other payors. The program aims to automate processes, including identifying relevant molecular tests, determining coverage policies, and establishing reimbursement rates. Dr. GBW stressed the increasing importance of automated solutions in the industry, especially with the growing number of tests.

Segment 2: Lessons Learned and Processes of MolDx by Valerie Collier, ARUP

Valerie Collier, with her extensive experience in MolDx, shared valuable insights and lessons learned. The process involves Technical Assessments (TAs), which require significant effort in areas such as background information, reporting, quality control, analytical validation, and clinical validation. TAs also involve evaluating clinical validity and utility by referring to clinical literature and guidelines. Collier discussed the challenges associated with obtaining representative clinical samples and stressed the importance of effective communication with medical directors to determine the required data. She emphasized the need to meet policy requirements, provide comprehensive information, and address any insufficiencies identified during the review process.

Segment 3: Insights on Z Codes and Reimbursement by Kyle Fetter, XIFIN

Kyle Fetter provided insights into the significance of Z Codes and their impact on reimbursement. Z Codes, used alongside CPT codes, provide valuable information to payors, enabling them to understand the specific tests performed. Fetter explained that while Z Codes contribute to reducing paperwork and requests for additional documentation related to the performed tests, they do not guarantee payment. He emphasized the importance of understanding that commercial plans may base their reimbursement rates on Medicare rates but are not bound by them. Fetter also highlighted the improvements observed in the prior authorization process and the reduction in denials after the implementation of Z Codes.

Panel Discussion and Q&A

The panel discussion covered various topics related to Z Codes, Technical Assessments, FDA-approved tests, and utilization management. The experts clarified that Z Codes are primarily required for Medicare jurisdictions, but compliance becomes necessary if specific commercial plans, such as UHC, demand their use. They also discussed the ongoing collaboration between laboratories and MolDx, the process for updating TAs when making changes to lab procedures, and the differences in review criteria between FDA-approved tests and Laboratory-Developed Tests (LDTs).

Additionally, the panel addressed questions regarding Z Code rates, the proprietary nature of Z Codes, the usage of Z Codes for in-house molecular tests, and the possibility of multiple registrations for labs. They emphasized the importance of test-specific Z Codes and the need for each lab to register its unique tests. The experts highlighted the ongoing efforts to streamline coverage and reduce administrative burdens while acknowledging the challenges associated with transparency, increased prior authorization requests, and potential inconsistencies in private payer rates.

User

Please summarize each of the questions individually.

ChatGPT

Certainly! Here's a summary of each question addressed during the webinar:

Question 1: Can Technical Assessments (TAs) be appealed if a lab fails the assessment?

Summary: TAs are tailored to specific services, and if a lab fails the assessment, collaboration and communication continue. The lab receives an insufficiency list to work on, and resubmission is always possible. Appeals can be made if the lab believes the assessment process was flawed.

Question 2: How long does a TA require, and who typically works on it?

Summary: The duration of a TA varies depending on the focus and any potential issues. On average, it takes about a week if the lab is focused and no major problems arise. The lab develops internal protocols for assembling TAs, involving medical directors, R&D scientists, and coordinated efforts. The process can be time-consuming but is essential for thorough assessment.

Question 3: What are the differences between Z codes, CPT codes, and ICD-9/ICD-10 codes?

Summary: CPT codes are the primary codes used for adjudication, while Z codes provide additional information about the specific tests performed. They are not replacements for CPT codes. ICD-9 and ICD-10 codes are used for diagnosis purposes and are separate from Z and CPT codes.

Question 4: Are there differences in the review process between FDA-approved tests and Laboratory-Developed Tests (LDTs)?

Summary: While FDA approval is important for assessing Analytical Validity (AV), MolDx reviews both AV and Clinical Validity and Utility (CU) to the same standards. The review process may involve disagreements with the FDA regarding AV, but that has rarely occurred.

Question 5: If a lab is located in a non-MolDx state, are Z codes still required?

Summary: MolDx is a Medicare program, so if a lab is not in a Medicare jurisdiction, Z codes are not required. However, if the lab works with UnitedHealthcare (UHC) and UHC demands Z code registry, compliance with Z codes is necessary.

Question 6: Will UHC start rejecting claims without Z codes and Technical Assessments (TAs)?

Summary: It is expected that UHC will reject claims without Z codes and TAs, although there might be some initial leeway during the transition period. Rejections are likely to occur shortly after the implementation date, August 1. The existence of subplans or exceptions was not clarified.

Question 7: When will the second wave of CPT codes be rolled out?

Summary: The speakers focused on the current wave of implementation and suggested focusing on that rather than speculating about future waves. No specific timeline was provided for the second wave of CPT codes.

Question 8: A lab in the 28 states relies on a reference lab located outside these states. The reference lab refuses to obtain a Z code. What should be done in this case?

Summary: If the reference lab is providing the service, it needs to register the test and obtain a Z code. The lab submitting the claim is responsible for ensuring compliance with the rules and requirements, including having a Z code. The reference lab must obtain a Z code for the specific test performed.

Question 9: Can Code 87999 be used for FDA-approved panels even if they have proprietary codes?

Summary: Code 87999 is typically not used if a proprietary code is available for FDA-approved panels. However, in certain cases where the proprietary code lacks clarity, Code 87999 might be considered. The general rule is to use the specific PLA code if available.

Question 10: Are the processes the same for small panels as for larger panels?

Summary: For small panels, referred to as subpanels, the same process is followed as for larger panels. The master validation platform is used, and the subpanels are submitted as individual Z codes under the master panel Technical Assessment. Each subpanel is accompanied by an executive summary to describe its indication and significance.

Question 11: If ARUP is the reference lab, can Z codes be obtained from them if needed?

Summary: ARUP can provide Z codes to another laboratory if they need them. Sharing Z codes is possible within the DEX registry, and the payer can also verify the authorized usage of Z codes by a lab.

Question 12: Why are Z codes considered proprietary and not viewable?

Summary: Z codes are considered proprietary due to the potential risks associated with unauthorized access. Only authorized users should have access to Z codes to prevent any misuse or disruption in the claims processing system.

Question 13: If the molecular test is conducted in-house, is a Z code still necessary?

Summary: Yes, if the molecular test is conducted in-house, a Z code is required. The location of the lab, whether it is within a hospital or not, does not affect the necessity of obtaining a Z code.

Question 14: Is there a limit to the number of individuals from a lab who can register for the DEX account?

Summary: ARUP currently allows two seats per lab for DEX account registration. It is unclear if this is their preferred number or if there is a cap on the number of registrations.

Question 15: Can a Z code be used for different tests?

Summary: Z codes are test-specific, and each unique test requires its own Z code. A lab may have multiple Z codes for different tests. If two labs perform the same test, it usually indicates an FDA-approved test that can share the same Z code.

Question 16: How many Technical Assessments (TAs) are received, how many are approved, and what is the current timeline for TAs?

Summary: On average, 100-300 TAs are received per week, but the success rate depends on the complexity of the service and the lab's performance. A global success rate is not provided, as it varies significantly. The current timeline for TAs is approximately two months, ensuring that labs receive a timely response.

CAP distributive model and Proficiency Testing

CAP QC documents refer to handling of reference tests under "distributed model"

 https://documents.cap.org/documents/2022-molecular-pt-recommendations.pdf

see also a deck at pierian on cap distributive model from 2018.

https://www.pieriandx.com/cap-distributive-model

###

Issues like this were on the agenda of CLIAC (CLIA AD COMM) in Nov 2021

https://www.cdc.gov/cliac/docs/april-2022/cliac_recommendationstable_apr2022.pdf

See a 2018 CDC deck on NGS validation

https://www.aphl.org/conferences/proceedings/Documents/2018/04-CDC%20QAQC%20CLIA-MacCannell.pdf

See a 2020 Nature article on analytical validation of WGS, Marschall et al.

https://www.nature.com/articles/s41525-020-00154-9

See HELIX get FDA authorization for a WES platform

https://www.prnewswire.com/news-releases/helix-laboratory-platform-granted-the-first-and-only-fda-authorization-for-a-whole-exome-sequencing-platform-301204899.html

Helix Letter here

https://www.accessdata.fda.gov/cdrh_docs/pdf19/DEN190035.pdf

As of June 2023, only the reclass order (7p) and not the "decision summary" are published.

Few devices like a "decision summary."

Overseas Studies

 A payor notes,

We routinely review and consider studies performed overseas. Elements such as study design and quality are universally important and are always a part of any review.  Additionally, for studies performed overseas, we evaluate whether the conclusions drawn would be applicable to US beneficiaries.  

For example, if physicians in another country follow cancer patients with an imaging schedule that is very different than that used in the US for a particular indication, study conclusions regarding lead times for MRD tests may be very different (and possibly not applicable) to patients in the US.  

Moreover, if a study population is primarily or exclusively composed of one racial or ethnic group, that might also impact the applicability of results to broader populations.  In this case, it is still possible that broader applicability across populations may have already been demonstrated in pre-existing clinical validity (CV) studies for the same analytes performed using a different test.

In short, our standards are the same, regardless of whether a study is performed in the US or overseas. Applicability to the intended-use population is a key feature no matter where a study is performed.

Very similar text is found in a June 2023 proposed evidence handbook for CMS NCDs.

https://www.cms.gov/medicare-coverage-database/view/medicare-coverage-document.aspx?mcdid=34&docTypeId=1&sortBy=title&bc=16

CMS routinely considers studies that are performed in whole or in part outside of the United States (OUS).  Whether outcomes from OUS studies may be generalized to the Medicare beneficiary population depends on multiple factors, but an important consideration is whether the study outcome depends on the care delivery context.  To the extent that health systems and practice standards differ between countries, an OUS study designed to show positive results may not be generalizable to the Medicare beneficiary population.  For example, an OUS study that aims to demonstrate that an intervention reduces hospitalizations may not be generalizable to the US if there are substantial differences in the types of (and coverage provided by) health insurance, hospital bed availability, and practice patterns between the US and the study country. Studies that include outcomes that may be sensitive to care delivery context (whether across different sites in the US or multi-country studies) should be appropriately designed and analyzed, potentially incorporating clustering or stratification into their statistical analysis plan.

Veracyte Nix Immunoscore 0261U

 https://www.veracyte.com/diagnostics/colon-cancer

[6 24 2023] 0261U

AN UPDATE ON THE IMMUNOSCORE COLON CANCER TEST

Dear Customer,

Thank you for your interest in the Immunoscore Colon Cancer test.

Veracyte has made the difficult decision to pause commercial efforts for the test, based on the need to prioritize our focus among the multiple tests in our portfolio. We are continuing to run and report Immunoscore Colon Cancer tests that were ordered through September 7, 2022.

Veracyte remains committed to immuno-oncology. We view this evolving field as a significant opportunity to help advance precision medicine for patients with cancer. To that end, we look forward to continuing to support important research with Immunoscore-based assays that support our biopharma and other partners.

If you have any questions, please contact our customer service team at 804-944-2009.

Sincerely,
The Veracyte Team

German Data for Health Conference 2023 (June 20-21)

 https://projekttraeger.dlr.de/media/events/dfh23/index.html

VIDEO

https://www.youtube.com/watch?v=i97FxDOcXNY

© BMG

Data for Health Conference 2023

Berlin, 20 June & 21 June 2023

The Federal Ministry of Health is organizing the high-​level "Data for Health Conference 2023" to discuss the framework and opportunities for using health data with experts from the United States and Europe.

What to expect

The recent years have revealed the enormous power of data. In the health sector, broad scale data utilization has been advancing medical knowledge by delivering data-driven discoveries, such as Artificial Intelligence (AI) technologies.

To further improve people’s lives, health data research revolutions require the adoption of governing regulations and policies to ensure safe and secure health data research. The Data for Health conference aims at bringing together the German, US and international health data and AI community, experts – from science to business –, policy makers and stakeholders to ensure we seize the broad range of opportunities arising from data-driven improvements to health and society. Data for Health will be an invite-only two-day event to spotlight discussions, encourage sharing of best practices regarding health data use and transatlantic access to health data and connect our health data and AI research projects funded by the Federal Ministry of Health.

Attendees of the conference will have the opportunity to explore a wide range of topics related to health data and its impact on patient care, policy, and innovation.

• High Level Keynotes from internationally experts across the health data sector
• Hands-on workshops and interactive panel discussions
• Digital Science Showcases featuring selected projects and new technologies
• Opportunities for Collaboration across a broad range of stakeholders

Information

Event date:

20 June & 21 June 2023

Venue:

Berlin
Alte Münze
Molkenmarkt 2
10179 Berlin

Organiser:

Federal Ministry of Health

Registration:

The event is on invitation only.

Program

Download Program

Tuesday, June 20th, 2023

9.00 am – 10.00 am	Arrival and Registration at Alte Münze, Molkenmarkt 2, 10179 Berlin, Germany Press conference Karl Lauterbach (German Federal Minister of Health) Jochen Lennerz (Harvard Medical School)
10.00 am – 10.30 am	Main Hall Opening keynote by Karl Lauterbach (German Federal Minister of Health)
10.30 am – 11.30 am	Main Hall Panel Discussion 1: Introduction to Data Sharing and AI Discussion on the benefits and challenges of data sharing and AI Alena Buyx (German Ethics Council) Roland Eils (Founding Director BIH Center for Digital Health) Tariq Khokhar (Wellcome Trust) Ariel Dora Stern (Harvard Business School)
11.30 am – 12.00 am	Coffee break
12.00 am – 1.00 pm	Main Hall Panel Discussion 2: Data Use and Data Sharing for AI Development Overview of data sharing platforms and tools, Discussion on how to create data sharing initiatives and standards Faisal Mahmood (Harvard Medical School) Lena Maier-Hein (German Cancer Research Center) Fruzsina Molnár-Gábor (University Heidelberg) Thorsten Schlomm (Charité – Universitätsmedizin Berlin) Sebastian Schneeweiss (Brigham and Women's Hospital, Harvard Medical School) Verpackungshalle Barcamps: Barcamp Sessions are open to all conference participants and no prior registration is necessary. (Download Barcamp Information) Session V1: NephroCAGE: Real-world Experiences from the German-Canadian Consortium on AI for Improved Kidney Transplantation Outcome. Matthieu Schapranow & Klemens Budde Session V2: What Can Germany learn from the Canadian Province of Alberta running one of the world’s largest digital health systems and their open dataculture? Daniel C. Baumgart Session V3: Data Sharing: only consent will work. It must be designed so that it can work. Stefanie Brückner Session V4: Accelerating Medical Progress with Large Language Models: A Brainstorming Session. Nils Krüger Session V5: Privacy Preserving Data Analysis - Code2Data Approaches Hannes Wünsche, Florian Schwarz, Toralf Kirsten, Sofia Maria Siampani Session V6: How to bring people living with diseases / citizens on board of the digital train to understand health data sharing across borders. Birgit Bauer & Ihno Fokken
1.00 pm – 2.00 pm	Lunch
2.00 pm – 4.00 pm	Main Hall Keynote by Özlem Türeci (BioNTech) Keynote and Q&A by John D. Halamka (Mayo Clinic) Panel Discussion 3: AI Applications and Innovation Nicholson Price (The University of Michigan Law School) Giorgio Quer (Scripps Research Translational Institute) Charlotte Tschider (Loyola University Chicago School of Law) Norman Zerbe (Charité – Universitätsmedizin Berlin) Zählhalle Barcamps: Barcamp Sessions are open to all conference participants and no prior registration is necessary. (Download Barcamp Information) Session Z1: Solidarity principle 2.0 – Data governance for health. Lutz Hager Session Z2: Reimagining Health Data Sharing: Innovating Beyond HIPAA and GDPR for a Global Framework. Jason Crites Session Z3: Interoperability of primary data collection and its impact on secondary data use. Stefanie Weber Session Z4: Real-Time Healthcare capacity Monitoring: Hospitals, Emergency Service and beyond Christian Karagiannidis Session Z5: Regulation of large language models - the most important health data question of the next 5 years? Stephen Gilbert Session Z6: How to operate international research projects GDPR-compliant with German data? Henrik Matthies & Jamie Blackport Verpackungshalle Interactive Workshop 1 Topic: Regulatory Science for AI – Overcoming regulatory barriers for the use of AI Lead: Jochen Lennerz, Susanne Ozegowski
4.00 pm – 4.30 pm	Coffee Break
4.30 pm – 5.30 pm	Main Hall Presentation of the Results of the Barcamps
5.30 pm – 8.00 pm	Meet our AI Projects and Networking with Food & Drinks Guided tours of the exhibition with short pitches by the exhibitors: Tour 1 (5.45 pm): AutoPiLoT (starting point, in the “Zählhalle”), SCP2, ENSURE, TraumAInterface, PerEpi, AkuSym, and KIPRODE Tour 2 (6.30 pm): HYKIST (starting point, in the “Lichthof”), DiBeA, SSTeP-KiZ, SATURN, and MOND Tour 3 (7.15 pm): EVA-KI (starting point, in the “Lichthof), KIperiOP, DIGIPD, SMART Start, and Leuko-Expert All tours start at the exhibition stalls of the first projects listed.
8.00 pm	End of Day 1

Wednesday, June 21st, 2023

8.30 am – 9.30 am	Arrival and Registration at Alte Münze, Molkenmarkt 2, 10179 Berlin, Germany
9.30 am – 10.00 am	Main Hall Keynotes by Robert Eiss (U.S. National Institutes of Health) Jochen Lennerz (Harvard Medical School)
10.00 am – 12.00 am	Main Hall Panel Discussion 4: Importance of the use of health data and transatlantic access to health data. Highlighting positive use cases and best practices Birgit Bauer (Data Saves Lives DE) Susan Gregurick (National Institutes of Health) Chikwe Ihekweazu (WHO Hub for Pandemic and Epidemic Intelligence) Lawrence Lessig (Harvard Law School) Eva Winkler (National Centre for Tumor Diseases) Panel Discussion 5: Transfer of research into practice, and innovation into healthcare. Highlighting positive use cases and best practices Rolf Apweiler (EMBL's European Bioinformatics Institute) Nisar Malek (Eberhard Karls University Tübingen) Fulvia Raffaeli (European Commission) Shannon Thor (Deputy Director of the FDA Europe Office) Verpackungshalle Interactive Workshop 2 Topic: Data against cancer Lead: Michael Hallek, Katharina Ladewig
12.00 am – 1.00 pm	Lunch
1.00 pm – 3.00 pm	Main Hall 1. High-level keynote Apple's approach to empowering people, medical researchers and healthcare providers. Sumbul Desai (Apple) 2. Presentation of the conference outcomes Presentation of the workshop results by Katharina Ladewig, Jochen Lennerz and Michael Hallek Hand over of conference results to Karl Lauterbach Concluding High-level moderated discussion: Participants: Karl Lauterbach (German Federal Minister of Health) Michael Hallek (University Hospital Cologne) Heyo K. Kroemer (Charité – Universitätsmedizin Berlin) Katharina Ladewig (Robert Koch Institut, Centre for Artificial Intelligence in Public Health Research) Jochen Lennerz (Harvard Medical School)
3.00 pm – 3.15 pm	Main Hall Closing Remarks by Woodward Clark Price (Deputy Chief of Mission U.S. Embassy) Closing of the conference by Karl Lauterbach (German Federal Minister of Health)
3.30 pm	End of the Conference

Speakers

We are looking forward to inspiring impulses from the following speakers, for example:

© BMG/Thomas Ecke

Prof. Dr. Karl Lauterbach
Federal Minister of Health

© The General Hospital Corporation

Prof. Dr. Jochen Lennerz
Harvard Medical School

© German Ethics Council/Reiner Zensen

Prof. Dr. Alena Buyx
German Ethics Council

© Harvard T.H. CHAN

Ray A Campbell
Harvard T.H. Chan School of Public Health

© Apple Inc

Dr. Sumbul Desai
Apple

© Sebastian Runge

Prof. Dr. Roland Eils
Berlin Institute of Health, Center for Digital Health

 

Robert Eiss
National Institute of Health (NIH) and Fogarty International Center

© WHO

Dr. Chikwe Ihekweazu
WHO Hub for Pandemic and Epidemic Intelligence

© private

Tariq Khokhar
Wellcome Trust

© Robin Heller

Dr. Katharina Ladewig
Robert Koch Institut, Centre for Artificial Intelligence in Public Health Research

© Jessica Scranton

Prof. Lawrence Lessig
Harvard Law School

© Tobias Schwerdt

Prof. Dr. Lena Maier-Hein
German Cancer Research Center

© Communication and Marketing, Heidelberg University

Prof. Dr. Fruzsina Molnár-Gábor
University Heidelberg

© Eva Hecht

Prof. Dr. med. Thorsten Schlomm
Charité - Universitätsmedizin Berlin

© Evgenia Eliseeva

Prof. Ariel Dora Stern
Harvard Business School

© Loyola University Chicago School of Law

Prof. Charlotte Tschider
Loyola University Chicago School of Law

© BioNTech SE

Prof. Dr. Özlem Türeci
BioNTech

© Media center of the Heidelberg University Hospital

Prof. Dr. Dr. Eva Winkler
National Center for Tumor Diseases (NCT) Heidelberg

© Digital Pathology Association

Prof. Dr. Norman Zerbe
Charité - Universitätsmedizin Berlin

More speakers to be announced soon!