Comparing Harvard Rough Notes and Chat GPT Article From Them

On September 22, 2023, there was a joint fireside chat by Dr Lauterbach, Minister of Health, Germany, and Dr Tripathi, who heads the HHS Office of the National Coordinator for Information Technology.  With my laptop on my lap, I typed 1400 words during the hour.   Chat GPT, with no further assistance, generated a clean 680 word article from my fragmented notes.

My (manual) Blog on the event:

https://www.discoveriesinhealthpolicy.com/2023/09/lecture-notes-german-health-ministers.html

The Auto-GPT article on the same event (also right column, here):

https://brucedocumentblog.blogspot.com/2023/09/ai-corner-lauterbach-at-harvard-kennedy.html

I should mention there is a bit of "symbiosis" here, I took typed notes to write my own article later, but I also took them with the thought in mind, they would be given as a "dump" to Chat GPT to test its writing skills.   

I have not tried to line up the two texts.

Rough Notes - Typed During Meeting

Chat GPT Article

1400 words German American Club Data and AI in Healthcare 2023 09 22   Dr Agrawal, Heidelberg and JHU.   Ulm.  Boston, postdoc Dana Farber.  Yavando Health empowers cancer patients in clinical trials.   Welcome, a translatlantic discussion, the German Health Minister, Dr Lauterbach, and at HHS, Dr Tripathi, Office of the National Coordinator (ONC-IT).   Dr. Lauterbach holds a Harvard SPH PhD.  He holds an adjunct professor there, and at the Univ Cologne.   Dr Tripathi holds an MS Public Policy Harvard, and PhD Poli Sci MIT.  He was a fellow at the Dept of Defense.  Twenty years of IT leadership experience, including Acadia, and Mass EHealth Colloborative.   In 2021, National Coordinator for Health IT (Biden).   Agrawal: Health data saves lives every day.   Q:  Where do you see the most tangible benefits? Thanks for the opportunity.  My remarks are brief.  We are behind on health IT tech and must catch up.  #1 is free of fossil energy and #2 is digital economy esp healthcare.  We are bringing in 4 new laws as priorities.   We work also with Dr Lennerz and colleagues here at Harvard.   We have 4 laws that cover two circles of data.  The outer circle is data for Care, and the inner is data for Research.   Connected.   We have 70M people to connect to a EHR by 2025 (opt out is possible).   10M may opt out.   Then we will have 70M people, 20,000 pharmacies, 1800 hospitals, 180,000 doctors offices.  Also labs.  So we get patient reports immediately in EHR.   The patient, too, can see the results.  Doctor may be given permission to see all the data, hospital, radiology, etc.   This is the outer sphere, which is encrypted but not anonymized.      The inner circle can pull the clinical data and cohort study and genomic data into the FRS the Federal Research Space, a confidential research space which is open (not encrypted) but anonymized.  Standard crawlers can analyze the data, it is a federal data space.   It will be a huge volume of data, by European standards, and will grow rapidly.   The system can be a training ground for AI systems.     Whether drug company or research questions, they get access to the data.   What are high level challenges?   KL:  If you want to train AI, you want to be absolutely sure there is data protection from the outside.   Make the data accessible and usable, but very confidential space.   The second issue, a fair amount of data is narrative data.  This should be however somewhat structured.  Or in retrospect will revise structure.   Who will do this?   “Lewins has partnered in the US” [?]   Retrospective structuring of data.    Q:  Dr Tripathi, How would you describe ONC priorities.   MT:  Thank you.   I listen to the minister with envy!!  For the top down authority he has.  We are very fragmented.   Our HC delivery system “isn’t a system” but loosely coupled providers and payers.   We don’t have the ability to say we’ll do everything in a big single database.   Not in 1M years.   We like to think the complexity makes us creative.   We’d like open architecture systems that free the data across the chain including the patient, payer, provider-provider etc.   Because we live in fragmentation, it’s AND logic - A AND B AND C.   In terms of priorities.   Spent $35B in incentives for EHR to lay the foundation.   We let them purchase any system that met a (low) bar.   We certify systems, and from 10% to 97% of hospitals and 86% of docs use a certified ONC system.   Things like CDS, new regs about AI in EHRs, predictive interventions.   That’s the digital foundation.   Now the next set?  What do we build, ON the foundation.   Resaerch, better quality, better continuity, better measures (e measures).   Modern inter operability.     Health equity by design.   Be sure these tech’s don’t amplify that.  Safety by design, security by design, equity by design.   With AI, we have some draft regulations  on venders to be transparent on embedded tools. Origin and uses, not regulation of the tool.   MGH has to decide, but give it 14 data elements.   Where the data came from, who paid for it, known risks, etc.   That’s in draft, final by EOY.   Agrawal:  Get your questions ready.   Agrawal:  Q.  There is excitement about new bills in the German cabinet, can you clarify?   KL:  We are working on 15 bills.  8 bills relevant here.   Digitalizing bills and hospital bills.  For Digital, passing cabinet, the universal EHR (with opt outs) 2025.   Basis for the research ring.    A digital research bill, the federal research space.   Some of the research is done by AI (Prediction) and Inference is done by people.  A genetics bill (I think) all new digital formats are inter operable.   IF it’s not inter operable, you can’t bill (affects sickness funds).   A fourth bill on medical research of all kinds, if you want to do any medical trial, in 21 working days, all the evaluation is done and in 5 days a decision.   We want to speed up the first patient in, day.   All the data can be provided digitally, not  in journal but English language, drugs can go direct to the sites.   THere is a hospital law that has to do with avoiding hospitalizations and better primary care.   Dr Tripathi, on inter operability.   We leverage 88% adoption only if we have intraop (which is different than adoption.)  How can we improve inter op?  Can AI aide in closing some gaps?   MT:  YOu have mutiple bills on the Hill.  We think of this as multi faceted.  There are miinimum data set standards.   We define the USCDI Core Data Inter Operability like vocab standards.  It grows, a rising floor.  This has spill over value, the APple Health Record buids on USCDI.   And FIRE API approach.   We don’t regulate Apple but it behooves them to piggy back on us.   We are doing extensions such as ISCDI-CANCER.      What is a restful API?   Take an app, but in name and password, and it connects.  21CC asks us to make HC discover the Internet - including API.   We have December 2022 FIRE restful API standard.   We can require this for payers as well, and state agencies and public health at CDC.   And data must be available to patients.   Venders have to allow use of a different but compliant API (competition for API UI).   Apple, Google, Saleforce, all jumping into HC and potentially via APIs.  Prior athor via API.    The last priority.   How we have a safe network backbone.   LIke in banking..   There are elaborate credit card or banking B2B rules and interfaces.  TEFKA will be that backbone.   As I opened by remarking, we have AND initiatives.   AGRAWAL:  Thank you both.   A softer question to KL.   Algorithms can be black boxes.  How do we ensure digital trust.     KL:  These standards are transparent.  If AI is used for recommendations or trials.   The system should be as transparent as possible.  Align #1, with all AI, you don’t know exactly how it works.   Align #2, there is the alignment, what data is used, and what was excluded and incuded.  Here, we can be clear.    We would work with a LLM that is as transparent as possible, Aleph Alpha may be there.    We have time for 2 brief audience questions.   MPA student.   What is Germany’s approach to accessibility to the health data?  Active ownership?   What about non digital society?  People without an ATM card?   KL:  EHR is opt out and granulated opt out, you can hide data you want to hide, such as hide only the psychiatric layer.   You can see all your data.   You can block R&D data.  YOu own the data and can always access it.   You don’t need tech expertise to use it.   You may never ever see your EHR but your doctors can enjoy using it.   SIDE : How do you opt out if you can’t use an app??   …You can ask your doctor to hide your data.   TRIPATHI:  There’s a lot of nuance.  Patients don’t own their US records.   They have only a “right of access” to a copy.     And patient can choose the app on which they request the copy or store it.   KL   The patient can destroy his data which he owns.   QUESTION LAST As a MD and Postdoc, I’m excited by the changes, but AI must learn from data that is good, and some exams and docs are (not so good!)   Won’t that be part of the AI?   University or wealthy patients may have more genomics, for example.   KL:

680 words On the 22nd of September, 2023, at the Harvard German American Club, an enlightening discussion took place on the topic of "Data and AI in Healthcare." The distinguished speakers were Dr. Lauterbach, the Health Minister of Germany, and Dr. Tripathi, the head of the Office of the National Coordinator (ONC) for US health data. The conversation, held at the Kennedy School of Government, was skillfully moderated by Dr. Agrawal of Harvard University.   Dr. Agrawal, who boasts affiliations with Heidelberg, Johns Hopkins University, and Dana Farber, opened the session by introducing the central theme - the critical role of health data in saving lives every day.   In response to the question of where the most tangible benefits of health data lie, Dr. Lauterbach underscored the need for Germany to catch up in health IT technology. He emphasized two key priorities: transitioning to fossil-free energy and fostering digital advancements, particularly in healthcare. Dr. Lauterbach outlined four forthcoming laws that would address these priorities, highlighting their collaboration with Dr. Lennerz and colleagues at Harvard.   The first set of laws pertains to two circles of data: the outer circle for Care and the inner circle for Research, both interconnected. By 2025, Germany aims to connect 70 million individuals to an Electronic Health Record (EHR), allowing for opt-out options. Within this network, 20,000 pharmacies, 1,800 hospitals, 180,000 doctors' offices, and laboratories would enable immediate EHR access to patient reports. This data can also be accessible to patients, with doctors potentially granted permission to access comprehensive medical information, including hospital and radiology reports.   The outer circle is encrypted but not anonymized, ensuring data security.   In contrast, the inner circle can access clinical, cohort, and genomic data, residing in the Federal Research Space (FRS). The FRS is a confidential, non-encrypted research space, open for analysis, and will serve as a valuable resource for AI systems. Researchers and organizations, including pharmaceutical companies, will gain access to this data for various purposes.   Addressing the challenges of data privacy and structure, Dr. Lauterbach stressed the importance of making data accessible yet keeping it confidential. He also recognized the need to structure narrative data for retrospective analysis, possibly through partnerships like "Lewins [?]."   Dr. Tripathi, speaking on ONC priorities, expressed admiration for the top-down authority held by Dr. Lauterbach. In contrast, the United States faces fragmentation in its healthcare delivery system. Instead of a unified database, the U.S. system comprises loosely connected providers and payers, making interoperability a complex challenge.   Dr. Tripathi highlighted the significant investments made in the U.S. to lay the foundation for digital health, including incentives for Electronic Health Record adoption. He discussed the need for modern interoperability, emphasizing health equity, safety, and security. Additionally, Dr. Tripathi mentioned draft regulations regarding transparency for AI tools, ensuring data origin, uses, and potential risks are known.   The discussion delved into audience questions, with Dr. Agrawal posing inquiries to both speakers. Dr. Lauterbach detailed Germany's legislative efforts, including digitalizing bills, universal EHR implementation by 2025, and a strong focus on medical research acceleration. [for example, a goal to approve research protocols in Germany in 30 days, much faster than today.]    Dr. Tripathi addressed the challenges of interoperability and the role of AI in closing these gaps. He also mentioned efforts to standardize data sets and promote accessibility, including through Application Programming Interfaces (APIs). [ONC rulemaking on AI here]   In closing, Dr. Agrawal touched on the importance of digital trust and transparency in AI algorithms. Dr. Lauterbach emphasized the need for transparency in AI systems and data usage.   The session concluded with brief audience questions, including inquiries about Germany's approach to health data accessibility and the challenges faced by patients in the U.S. regarding their medical records. Dr. Lauterbach highlighted Germany's granulated opt-out system and patient ownership of data, while Dr. Tripathi discussed the nuances of patient rights and data access in the U.S.   In summary, the discussion shed light on the evolving landscape of healthcare data and AI, highlighting both the progress and challenges faced by Germany and the United States in harnessing the potential of these technologies to improve healthcare outcomes.

 

Sidebar 4: Four Scripts, Four Tones, On The FDA LDT Proposals

I used my long blog on this topic as input for a 3 minute video script.   

There are several scripts below, the first entirely neutral (or FDA favorable, based on FDA talking points.)  The second and third are progressively more tilted to a lab industry concerned about regulation. The final fourth script is shrill and loudly protests against the proposed regulation which is portrayed as all-bad.

We lighten up with a bonus, a monolog a la' Louis Black.  Then, a final 5 minute, longer script in journalistic style, pretty close to one that could actually be used.

###

[INPUT:  BLOG AND REQUEST FOR 3 MINUTE SCRIPT]

CHAT GPT

Certainly, I can help you create a 3-minute video script based on the provided blog article. Here's a script that covers the key points:

#1  ==========================================

[Opening Shot]

[Background Music]

Narrator (Voiceover): "On September 29, 2023, the FDA unveiled a long-awaited regulation that could reshape the landscape of laboratory-developed tests."

[Cut to Images of FDA Building and the Rule Document]

Narrator (Voiceover): "The rule, which had been eagerly anticipated, was released in typescript form, with the official publication in the Federal Register scheduled for October 3."

[Transition to Graphics of the FDA Press Release and Federal Register Rule Page]

Narrator (Voiceover): "For laboratory and FDA policy experts, this regulation marks a significant milestone in the lab-developed test industry."

[Cut to Image of FDA Leadership]

Narrator (Voiceover): "It's the result of the FDA's clear stance that they would step in with regulation if Congress didn't pass specific legislation, such as the VALID Act."

[Zoom in on the Core Change]

Narrator (Voiceover): "But what exactly does this regulation entail? At its core, it's a micro regulatory change."

[Show Rule Text]

Narrator (Voiceover): "The FDA explicitly defines a test as an in vitro diagnostic device (IVD) when its manufacturer is a laboratory."

[Transition to Marketing Claims]

Narrator (Voiceover): "The regulation, however, isn't just about definitions. It also addresses marketing claims and performance, giving substantial weight to both."

[Show Section on Costs and Benefits]

Narrator (Voiceover): "The FDA estimates the financial benefits could range from 2 to 86 billion dollars, with the best estimate at 22 billion dollars."

[Cut to FDA Justification]

Narrator (Voiceover): "The FDA's justification for this change is extensive. It cites concerns about under-regulation in certain testing areas, especially non-invasive prenatal screening (NIPS)."

[Show FDA Concerns]

Narrator (Voiceover): "The agency has witnessed a surge in the volume, complexity, and scope of IVDs offered as LDTs, particularly in cancer treatment decision-making."

[Transition to Compliance]

Narrator (Voiceover): "As for compliance, the FDA's proposed phased approach outlines five stages."

[Show Timeline]

Narrator (Voiceover): "These stages range from ending enforcement discretion for Medical Device Reporting to premarket review requirements."

[Show Third-Party Review]

Narrator (Voiceover): "Laboratories can also consider third-party review programs, potentially streamlining the process."

[Transition to Economic Impact]

Narrator (Voiceover): "The rule includes a detailed economic analysis, assessing potential costs and benefits."

[Show Benefits]

Narrator (Voiceover): "The goal? Ensuring the safety and effectiveness of LDTs, addressing concerns about their quality and performance."

[Cut to Risk Categories]

Narrator (Voiceover): "The FDA categorizes LDTs into risk categories, differentiating between high-risk and moderate to low-risk tests."

[Show Timeline]

Narrator (Voiceover): "This approach allows the FDA to prioritize high-risk tests while giving labs time to comply with regulatory requirements."

[Closing Shot]

Narrator (Voiceover): "In summary, the FDA's new regulation may bring substantial changes to the laboratory-developed test industry. Stay tuned as this policy unfolds."

[Background Music Fades]

This script provides an overview of the key points from your blog article and can serve as a basis for creating a 3-minute video. You can add visuals, graphics, and additional details as needed to complement the narration.

User

That's fair, and very even handed.   

However, most of the viewers of the video will be from the lab industry and will be opposed to more regulatory costs and burdens.   Could you write the script with that audience in mind,  however, still maintaining a mostly neutral tone.   

It should still be even handed journalism, just considering that the audience will not be so pleased and will be interested in their options for comment periods and the possibility of court challenges to slow down the change.  

ChatGPT

Of course, I can provide a script with a focus on the lab industry's perspective while maintaining a balanced tone. Here's a revised script:

#2 ==========================================

[Opening Shot]

[Background Music]

Narrator (Voiceover): "On September 29, 2023, the FDA unveiled a long-anticipated regulation that's poised to impact the lab-developed test industry."

[Cut to Images of FDA Building and the Rule Document]

Narrator (Voiceover): "But for those within the laboratory industry, this regulation brings both challenges and opportunities."

[Transition to Graphics of the FDA Press Release and Federal Register Rule Page]

Narrator (Voiceover): "The FDA's announcement comes after months of speculation, with the official publication in the Federal Register scheduled for October 3."

[Cut to Image of FDA Leadership]

Narrator (Voiceover): "Many within the lab industry had been watching closely, especially as the FDA had made it clear that if Congress didn't pass specific legislation, such as the VALID Act, they would step in with regulation."

[Zoom in on the Core Change]

Narrator (Voiceover): "So, what's the core change? At its heart, it's a micro regulatory shift."

[Show Rule Text]

Narrator (Voiceover): "The FDA now explicitly defines a test as an in vitro diagnostic device (IVD) when its manufacturer is a laboratory."

[Transition to Marketing Claims]

Narrator (Voiceover): "But this regulation isn't just about definitions. It also delves into marketing claims and performance, factors that have raised concerns."

[Show Section on Costs and Benefits]

Narrator (Voiceover): "The FDA estimates the financial benefits could range from 2 to 86 billion dollars, with the best estimate at 22 billion dollars."

[Cut to FDA Justification]

Narrator (Voiceover): "The FDA's justification for this change is extensive. It cites concerns about under-regulation in certain testing areas, especially non-invasive prenatal screening (NIPS)."

[Show FDA Concerns]

Narrator (Voiceover): "Additionally, the agency has seen a surge in the volume, complexity, and scope of IVDs offered as LDTs, particularly in cancer treatment decision-making."

[Transition to Compliance]

Narrator (Voiceover): "Now, let's talk compliance. The FDA's proposed phased approach outlines five stages."

[Show Timeline]

Narrator (Voiceover): "These stages range from ending enforcement discretion for Medical Device Reporting to premarket review requirements."

[Show Third-Party Review]

Narrator (Voiceover): "One option for labs is to consider third-party review programs, which could streamline the process."

[Transition to Economic Impact]

Narrator (Voiceover): "The rule includes a detailed economic analysis, assessing potential costs and benefits."

[Show Benefits]

Narrator (Voiceover): "The goal? Ensuring the safety and effectiveness of LDTs, addressing concerns about their quality and performance."

[Cut to Risk Categories]

Narrator (Voiceover): "The FDA categorizes LDTs into risk categories, differentiating between high-risk and moderate to low-risk tests."

[Show Timeline]

Narrator (Voiceover): "This approach allows the FDA to prioritize high-risk tests while giving labs time to comply with regulatory requirements."

[Closing Shot]

Narrator (Voiceover): "In summary, the FDA's new regulation presents a mixed bag for the laboratory industry. As they assess its impact, they may explore options for comment periods and even consider legal challenges to influence the pace of change."

[Background Music Fades]

This revised script maintains a neutral and even-handed tone while focusing on the lab industry's perspective, acknowledging their concerns and potential courses of action. It provides a balanced view of the situation for viewers within the lab industry.

User

Ok that's a great benchmark and exactly what I asked for.  

Could we now do a script more favorable to the current lab inidustry, raising concerns about costs ($5B for the lab industry), swamping the FDA's staff with high numbers of applications, and impairing innovation by adding regulation.   The FDA seems to have written this to stack arguments in its favor, and in favor of more regulation, but it's not a full picture if the public only reads the FDA's own story and not a multi stakeholder view.

ChatGPT

Certainly, I can provide a script that highlights concerns from the current lab industry perspective, focusing on potential costs, regulatory burdens, and their impact on innovation. Here's the script with that angle:

#3  ==========================================

[Opening Shot]

[Background Music]

Narrator (Voiceover): "On September 29, 2023, the FDA introduced a new regulation that's poised to reshape the lab-developed test industry."

[Cut to Images of Lab Facilities and Lab Technicians]

Narrator (Voiceover): "For those within the lab industry, this regulation raises some serious concerns."

[Transition to Graphics of FDA Announcement and Rule Document]

Narrator (Voiceover): "After months of anticipation, the FDA's regulation was officially announced, with publication in the Federal Register scheduled for October 3."

[Cut to Image of Concerned Lab Executive]

Narrator (Voiceover): "Many leaders in the lab industry have been watching closely, and their concerns are growing."

[Zoom in on the Core Change]

Narrator (Voiceover): "At its core, this regulation signifies a significant shift in regulatory oversight."

[Show Rule Text]

Narrator (Voiceover): "The FDA now explicitly classifies tests as in vitro diagnostic devices (IVDs) when the manufacturer is a laboratory."

[Transition to Regulatory Burdens]

Narrator (Voiceover): "But what's causing unease? Regulatory burdens and their potential consequences."

[Show Section on Costs and Benefits]

Narrator (Voiceover): "The FDA estimates that compliance costs for the lab industry could soar to a staggering 5 billion dollars."

[Cut to Concerned Lab Professionals]

Narrator (Voiceover): "These costs, coupled with the sheer volume of applications expected to flood the FDA, could overwhelm their staff."

[Transition to Impact on Innovation]

Narrator (Voiceover): "Innovation is also at stake. The lab industry fears that this added layer of regulation might stifle creativity."

[Show FDA Justification]

Narrator (Voiceover): "While the FDA cites concerns about under-regulation, many within the lab industry argue that existing quality control measures are robust."

[Transition to Compliance Challenges]

Narrator (Voiceover): "Compliance with the proposed phased approach brings its own set of challenges."

[Show Timeline]

Narrator (Voiceover): "These stages range from ending enforcement discretion to premarket review requirements, raising questions about feasibility."

[Cut to Lab Innovators]

Narrator (Voiceover): "Innovation thrives in environments that encourage experimentation and advancement. Some fear that these new regulations could hinder that spirit."

[Closing Shot]

Narrator (Voiceover): "In summary, the FDA's regulation presents a complex landscape for the lab industry. The concerns over costs, potential staff overload, and impacts on innovation are very real."

[Background Music Fades]

This script offers a viewpoint from the current lab industry perspective, emphasizing their concerns about costs, regulatory burdens, and potential impacts on innovation. It maintains an even-handed tone while highlighting these industry-specific worries.

Great.   Now a 3 minute script, that is from a group representing the lab industry, opposed to any new regulation, and views this is a land grab by FDA for overzealous regulators.  The FDA can't possibly staff up to regulate thousands or tens of thousands of test, and their revisions, and doesn't even pretent to have a plan to do so.   Billions in costs are unaccounted for, and the severe damage to lab industry innovation via LDT tests, will be tragic.   Continue in this vein.   

#4 (Hostile)  ==========================================

ChatGPT

Certainly, here's a 3-minute script from the perspective of a group representing the lab industry, strongly opposed to the new regulation and expressing concerns about the FDA's ability to implement it effectively:

[Opening Shot]

[Background Music]

Narrator (Voiceover): "In the world of laboratory-developed tests (LDTs), a storm is brewing, and the lab industry is raising its voice."

[Cut to Images of Lab Facilities and Lab Technicians]

Narrator (Voiceover): "The FDA's recent regulatory proposal is causing quite a stir, and not in a good way."

[Transition to FDA Announcement Graphics]

Narrator (Voiceover): "With the FDA's announcement fresh in everyone's minds, the lab industry has some serious reservations."

[Cut to Image of Concerned Lab Executive]

Narrator (Voiceover): "Let's break it down. Why the uproar?"

[Zoom in on the Core Change]

Narrator (Voiceover): "At the heart of this issue is a seemingly small but potent change."

[Show Rule Text]

Narrator (Voiceover): "The FDA now categorizes tests as in vitro diagnostic devices (IVDs) when labs are the manufacturers."

[Transition to Regulatory Concerns]

Narrator (Voiceover): "But what's got the lab industry up in arms? 

Regulatory nightmares and unanswered questions."

[Show Section on Costs and Benefits]

Narrator (Voiceover): "The FDA estimates compliance costs for the lab industry could hit a jaw-dropping billion-dollar figure."

[Cut to Concerned Lab Professionals]

Narrator (Voiceover): "And this is only part of the problem. Imagine the FDA staff swamped by thousands of applications, with no clear plan to handle them."

[Transition to Crushing Innovation]

Narrator (Voiceover): "Then there's the innovation dilemma. The lab industry fears this regulation will slam the brakes on creativity."

[Show FDA Justification]

Narrator (Voiceover): "While the FDA cites concerns about under-regulation, many in the lab industry argue that existing quality control measures are robust."

[Transition to Compliance Chaos]

Narrator (Voiceover): "Navigating the proposed phased approach is a labyrinth of challenges."

[Show Timeline]

Narrator (Voiceover): "From ending enforcement discretion to premarket review requirements, it's a roadmap to chaos and uncertainty."

[Cut to Lab Innovators]

Narrator (Voiceover): "Innovation thrives when barriers are low, and bureaucracy is minimal. The lab industry dreads that these new regulations will crush that spirit."

[Voiceover Shifts to Firm Tone]

Narrator (Voiceover): "In conclusion, the lab industry is sounding the alarm. They see this regulation as a land grab by overzealous regulators."

[Show Images of Protests or Opposition]

Narrator (Voiceover): "Billions in costs are unaccounted for, and the potential damage to lab industry innovation via LDT tests is nothing short of tragic."

[Voiceover Gains Emphasis]

Narrator (Voiceover): "It's not just about what the FDA says it will do; it's about what they can realistically achieve."

[Closing Shot]

Narrator (Voiceover): "The lab industry isn't taking this lightly. They're gearing up for a battle, ready to protect their turf and the innovative spirit that's been their hallmark."

[Background Music Fades]

This script portrays a strong opposition perspective from a group representing the lab industry, highlighting concerns about costs, regulatory chaos, and potential harm to innovation. It maintains a firm tone throughout while expressing their reservations about the FDA's ability to handle the proposed changes effectively.

BONUS
LOUIS BLACK

Now, instead of an anti-FDA script, which you have just written, a short monolog against the FDA proposal in a similar tone but in the voice of comedian Louis Black.

ChatGPT

[Opening with Louis Black's trademark exasperated tone]

Louis Black: "Ladies and gentlemen, gather 'round, because it's time for a comedy of errors brought to you by the FDA!"

[Expressive Hand Gestures]

Louis Black: "So, the FDA, in all its wisdom, decides it's time to drop a regulatory bomb on the lab-developed test industry. I mean, come on, folks!"

[Mocking Surprise]

Louis Black: "What's their brilliant plan? They say, 'Hey, let's call these tests in vitro diagnostic devices (IVDs) when labs make 'em.'"

[Facepalm]

Louis Black: "Well, ain't that a groundbreaking idea! The kind of idea that must've taken, what, five minutes to come up with?"

[Imitating FDA]

Louis Black: "We've got problems with lab-developed tests, let's just slap the 'IVD' label on 'em, and voila! Problem solved!"

[Sarcastic Applause]

Louis Black: "Give 'em a round of applause, folks! The FDA's done it again!"

[Switching to Mock Seriousness]

Louis Black: "But wait, there's more! The FDA thinks this little change will only cost the lab industry a cool billion dollars or more."

[Rolling Eyes]

Louis Black: "Oh, great! Because, you know, labs have cash lying around like spare change in the sofa cushions."

[Sarcastic Excitement]

Louis Black: "And, here's the best part! The FDA doesn't have a clear plan to handle the flood of applications that'll come their way."

[Incredulous]

Louis Black: "Can you believe it? It's like they're saying, 'Let's launch a thousand ships without a captain and see what happens!'"

[Shaking Head]

Louis Black: "But, hey, innovation, who needs it, right? The FDA's here to put a stop to all that creativity!"

[Mocking Tone]

Louis Black: "Because we all know that innovation happens best when you drown it in paperwork and bureaucracy!"

[Resigned Laughter]

Louis Black: "So there you have it, folks, the FDA's grand plan. It's like they're playing a game of regulatory Jenga, and they're pulling out the pieces left and right."

[Concluding with a Sigh]

Louis Black: "But hey, what do I know? I'm just a comedian. The FDA's the one with all the answers!"

[Exaggerated Eye Roll]

Louis Black: "Good luck, lab industry, you're gonna need it!"

[Louis Black's Trademark Frustrated Gesture]

Louis Black: "And that's the FDA for ya!"

[Exit with a Dramatic Wave]

Louis Black: "I'm Louis Black, and this has been your dose of FDA absurdity. Don't forget to laugh through the tears, folks!"

[End with Louis Black's Signature Exasperated Expression]

This monologue takes a comedic and exasperated approach to critique the FDA proposal, highlighting the absurdity of some of its aspects while maintaining Louis Black's trademark humor.

###

###

All right, let's go back to my original blog article describing the FDA's plan.   Write a 5 minute video script explaining it to lab industry experts who are moderately concerned about over regulation or the FDA becoming overloading, but not over the top on this concern.   

I suggest a 5 minute video (earlier ones were 3 minutes or less) to allow more detail from the blog article and FDA plan.

ChatGPT

[Opening shot: A laboratory setting with lab technicians working.]

Narrator (Voiceover): "In the world of diagnostics, precision and innovation are key. But what happens when the regulatory landscape shifts?"

[Cut to a close-up of a computer screen displaying the FDA's website.]

Narrator (Voiceover): "On September 29, 2023, the FDA released its much-anticipated regulation to control the lab-developed test industry."

[Cut to the FDA's press release on the computer screen.]

Narrator (Voiceover): "This rule comes after months of speculation and discussions within the industry and among policymakers."

[Transition to a montage of newspaper headlines and articles discussing the FDA's proposal.]

Narrator (Voiceover): "It's a topic that's been making headlines and sparking debates. But what does this FDA proposal mean for the lab industry?"

[Cut to a calm and composed expert in a laboratory coat, standing in a lab.]

Expert: "Hello, I'm here to help shed some light on the FDA's recent proposal and what it might mean for our industry."

[Text on screen: Expert Insights]

Expert: "First, let's address the core change in this proposal. The FDA is making explicit that a test is considered an in vitro diagnostic device (IVD) when its manufacturer is a laboratory."

[Cut to a screenshot of the relevant FDA document.]

Expert (Voiceover): "This seemingly simple change can have significant implications. It means that certain lab-developed tests (LDTs) will now be subject to FDA regulation."

[Cut to the expert holding a printed copy of the FDA's proposal.]

Expert: "The FDA's justification for this change is rooted in concerns about under-regulation, performance variability, and the need for better oversight."

[Cut to an animated graphic showing a timeline.]

Narrator (Voiceover): "Now, let's dive into the proposed phased approach. The FDA suggests a five-stage plan."

[Text on screen: Proposed Phased Approach]

Expert (Voiceover): "In the first stage, they want to end enforcement discretion with regard to Medical Device Reporting (MDR) and correction and removal reporting requirements."

[Cut to a timeline graphic highlighting each stage.]

Expert (Voiceover): "Stage two expands the scope to include requirements like registration and listing, labeling, and investigational use."

[Cut to the expert in front of a whiteboard.]

Expert: "Stage three focuses on Quality System (QS) requirements, particularly for LDTs manufactured within a single Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory."

[Cut to the expert holding a clipboard.]

Expert: "Now, in stage four, things get a bit more serious. It's about ending enforcement discretion for high-risk IVDs offered as LDTs."

[Cut to a shot of a high-tech laboratory machine.]

Expert (Voiceover): "And finally, stage five extends that to moderate and low-risk IVDs, requiring premarket submissions like 510(k) or De Novo requests."

[Cut to the expert in the lab.]

Expert: "But what does all of this mean for us?"

[Cut to a graphical representation of costs and benefits.]

Narrator (Voiceover): "According to the FDA's preliminary analysis, the financial benefits could range from $2 billion to $86 billion, with a best estimate of $22 billion."

[Cut to the expert.]

Expert: "Now, let's talk about the elephant in the room: costs."

[Text on screen: Costs]

Expert: "The FDA acknowledges that compliance costs could be around $6 billion [BQ per year average 20 years, but $30-40B in first years]. And that's where our concerns come in."

[Cut to an animated graphic showing potential consequences.]

Narrator (Voiceover): "With billions at stake, some worry that this could burden the lab industry, lead to delays, and even affect innovation."

[Cut to a shot of lab technicians working diligently.]

Expert: "We've built a thriving industry with a focus on delivering quality diagnostics swiftly. The concern is that additional regulation might slow us down."

[Cut to the expert in front of a laboratory setting.]

Expert: "But let's be clear; we all want to ensure the safety and effectiveness of tests. It's a matter of finding the right balance."

[Text on screen: Finding Balance]

Expert: "The FDA believes that this phased approach provides that balance. They want to prioritize high-risk tests while giving labs time to adapt."

[Cut to an animated graphic summarizing the proposed phases.]

Narrator (Voiceover): "So, what's next?"

[Text on screen: What's Next?]

Expert (Voiceover): "The proposed rule is now open for comments until November 29. It's a chance for our industry to voice concerns, suggest improvements, and influence the final regulations."

[Cut to a shot of the expert reviewing the FDA proposal.]

Expert: "It's essential for all stakeholders, including labs, to participate in this process."

[Cut to the expert in front of a lab backdrop.]

Expert: "In conclusion, the FDA's proposal is a significant development for our industry. While it may bring challenges, it also offers opportunities for collaboration and improvement."

[Text on screen: Collaboration & Improvement]

Expert: "Let's work together to ensure that our industry continues to provide the highest quality diagnostics to those who need them."

[Closing shot: The expert standing confidently in the lab.]

Expert: "Thank you for joining me today, and let's keep the dialogue open as we navigate these changes together."

[Text on screen: Stay Informed]

Narrator (Voiceover): "Stay informed, stay engaged, and let your voice be heard."

[End with the expert's reassuring smile.]

##

This 5-minute video script provides a balanced overview of the FDA's proposal for the lab industry, acknowledging concerns while emphasizing the importance of participation and collaboration during the comment period.

AI SUMMARY OF CLIA AC WORKGROUP REPORT NGS

 

https://www.cdc.gov/cliac/docs/addenda/cliac0419/10a_ngs_workgroup_report.pdf

 

CLINICAL LABORATORY IMPROVEMENT ADVISORY COMMITTEE (CLIAC) 

NEXT GENERATION SEQUENCING (NGS) 

WORKGROUP SUMMARY REPORT

 

Workgroup Charge

 

Provide input to CLIAC for consideration in developing recommendations to CDC, CMS, and FDA for assuring the quality of next generation sequencing based testing in clinical laboratory settings.

 

Workgroup Tasks

 

• Identify challenges in applying the existing regulatory framework • Identify challenges and gaps in guidance • Consider and suggest strategies to address the identified gaps and challenges • Consider and suggest strategies for assuring workforce competency

 

 AI SUMMARY

This document comprises a working group report submitted to the Centers for Medicare & Medicaid Services (CMS) CLIA division, addressing policy issues within the realm of next-generation sequencing (NGS). It encompasses a compilation of publications and guidelines that collectively provide a comprehensive framework for laboratories and stakeholders involved in NGS-based clinical diagnostics. These guidelines address critical aspects of quality assurance, validation, variant interpretation, regulatory compliance, and personnel qualifications in the context of NGS applications for clinical purposes. Adhering to these guidelines is essential to ensure the accuracy and reliability of NGS testing in a clinical setting, ultimately improving patient care and outcomes. Laboratories should stay updated with these evolving standards and practices to deliver high-quality NGS-based diagnostic services.

 

 

Here's a detailed summary of the key points and themes from these publications:

1.     Quality Assurance and Good Laboratory Practices: Several publications emphasize the importance of maintaining high-quality standards in NGS laboratories. They highlight the need for rigorous quality control procedures to ensure the accuracy and reliability of NGS data. Quality assurance is critical to meet the clinical standards required for patient care.

2.     Validation and Proficiency Testing: Validation of NGS assays is crucial to ensure that they perform as intended. These guidelines provide recommendations on how to validate clinical NGS assays, including germline and somatic variant detection. Proficiency testing programs are also discussed, emphasizing the need for interlaboratory agreement to maintain consistency in results across different facilities.

3.     Variant Interpretation: To effectively use NGS in clinical diagnostics, guidelines have been established for the interpretation of sequence variants. These guidelines aim to standardize the process of variant classification, ensuring that variants are accurately categorized as pathogenic, likely pathogenic, benign, or of uncertain significance. Consistency in variant interpretation is vital for clinical decision-making.

4.     Somatic Genetic Variant Detection: Specific guidelines focus on NGS applications for the detection of somatic genetic variants in oncology. These documents outline considerations for the design, development, and analytical validation of NGS-based in vitro diagnostics (IVDs) for cancer diagnosis. They address issues related to clinical validity and public genetic variant databases' use in supporting diagnostic accuracy.

5.     Regulatory Considerations: The guidelines from the Food and Drug Administration (FDA) are particularly important, as they offer guidance for stakeholders and FDA staff regarding the development and validation of NGS-based IVDs. These documents outline regulatory expectations for diagnostic developers and provide insights into the use of public genetic variant databases to support clinical validity.

6.     Infectious Disease Testing: Some publications delve into the application of NGS for the identification and characterization of infectious agents, especially in isolates. These guidelines aim to standardize the use of NGS in infectious disease diagnostics, ensuring accurate and reliable results.

7.     Educational Framework: The documents also highlight the need for education and competency assessment in NGS laboratories. They discuss the qualifications and competencies required for personnel involved in NGS testing, emphasizing the importance of continuous training and assessment.

8.     Laboratory Workflow: The guidelines touch upon laboratory workflow considerations, including how to determine annual testing volumes for NGS. They discuss billing practices and the use of test names and Common Procedural Technology (CPT) codes for tracking NGS tests.

In summary, these publications and guidelines collectively provide a comprehensive framework for laboratories and stakeholders involved in NGS-based clinical diagnostics. They address critical aspects of quality assurance, validation, variant interpretation, regulatory compliance, and personnel qualifications. Adhering to these guidelines is essential to ensure the accuracy and reliability of NGS testing in a clinical setting, ultimately improving patient care and outcomes. Laboratories should stay updated with these evolving standards and practices to deliver high-quality NGS-based diagnostic services

 

Rough Links: ONC Rulemaking and AI Issues (Spring 2023)

 ONC BLOG April 13 - Transparency of AI in HC

https://www.healthit.gov/buzz-blog/health-innovation/transparent-and-trustworthy-ai-in-health-care

ONC FORMAL PROPOSED RULEMAKING APRIL 18

https://www.federalregister.gov/documents/2023/04/18/2023-07229/health-data-technology-and-interoperability-certification-program-updates-algorithm-transparency-and

"Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing"

######

BECKER DATA JULY 19

Amazon pushes back on ONC rules

https://www.beckershospitalreview.com/disruptors/amazon-google-push-back-against-oncs-predictive-healthcare-ai-rules.html

FEDSCOOP June 28

https://fedscoop.com/hhs-health-it-division-carving-out-artificial-intelligence-niche/

MCDERMOTT June 14

https://www.ofdigitalinterest.com/2023/06/inside-the-oncs-plans-to-regulate-health-ai-proposal-on-predictive-decision-support-interviews/

McD Report:

https://www.mwe.com/pdf/inside-the-oncs-plans-to-regulate-health-ai-proposal-on-predictive-decision-support-interviews/

NATL LAW REV June 14 (From McDermott)

(Same)

https://www.natlawreview.com/article/inside-onc-s-plans-to-regulate-health-ai-proposal-predictive-decision-support

##

JHU's Welch and Mammography Risk Modeling

Recent  USPSTF recommendations for colon cancer screening, lung cancer screening, and mammography have made significant use of modeling, and in the last few years, all three of these recommendations have seen expanded indications.   For example, mammography is recommended now age 40-50 (but every other year) based on 2023 expected updates.

Woloshin et al, senior author Gilbert Welch at Johns Hopkins, dissent.  In NEJM they write, 

"The USPSTF’s increasing reliance on complex statistical modeling is problematic. Estimated effects can be extremely sensitive to modeling assumptions, which often reflect the conventional wisdom at the time...As others have argued, policymakers should use models only if they understand the parameters and assumptions underlying them."

###

Welch made headlines a few weeks ago when JAMA Internal Medicine published a group of articles on liquid biopsy and multi cancer screenning; one of the main artices focused on overall survival. Op Ed by Welch & Dey.

Chat GPT Discusses WSJ Op Eds vs CMS Press Response

 https://www.discoveriesinhealthpolicy.com/2023/09/unprecedented-cms-press-release-insists.html

Policy Analysis: Discussion of Articles One & Two Versus Article Three

In the realm of healthcare policy, the allocation of resources and the impact of coverage decisions on patient outcomes are contentious issues. This analysis discusses the contrasting perspectives of three articles on Medicare coverage for blood tests used to monitor organ transplant rejection.

Articles One & Two: Perspective and Concerns

Articles One and Two, both from WSJ / The Editorial Board, present a critical view of Medicare’s policy regarding the coverage of blood tests for transplant patients, alleging a detrimental cost-cutting measure at the expense of patient care. Both articles emphasize the crucial role these blood tests play in the early detection of organ rejection, thereby allowing for timely intervention and potentially saving lives and organs.

1. Issue of Cost:

   • Both articles underline the high cost of the blood tests (ranging from $2,800 to $3,200 each), implying a financial motive behind Medicare's policy change.
   • Highlighting that the denial of coverage is a cost-cutting strategy, Article Two quotes a policy chairman terming it a “blunt instrument of cost control.”

2. Impact on Patient Care:

   • Articles One and Two argue that early detection through these non-invasive blood tests is vital for patient outcomes.
   • The articles convey concerns from various stakeholders, including doctors and patients, regarding the potential health risks associated with the policy change.

3. Alternatives to Blood Tests:

   • Article One notes that the alternative to blood tests is an invasive biopsy, which is not only costly but also may be conducted too late to save the organ.

4. Reaction from Medical Community and Lawmakers:

   • Both articles mention the medical community's opposition to the policy change.
   • Article One details letters from major transplant societies to the contractor, while Article Two emphasizes testimonies from patients and experts on the essential nature of these tests.
   • A bipartisan letter from Congress members is mentioned in Article One, calling for the restoration of coverage.

Article Three: CMS Statement

Article Three provides the perspective of the Centers for Medicare & Medicaid Services (CMS), which contradicts the narratives presented in Articles One and Two.

1. Clarification of Policy:

   • CMS asserts that there have been no changes affecting patients’ ability to have blood tests used for organ transplantation rejection covered when ordered by their physicians in medically appropriate circumstances.
   • It frames the policy as a clarification rather than a change, and assures that these tests can still be used in place of a more invasive biopsy.

2. Addressing Improper Billing and Overutilization:

   • CMS highlights issues with improper billing and overutilization of these tests.
   • The agency states that the revision in billing instructions was a response to these issues to help providers better understand the existing LCD criteria language.

3. Continuous Access to Blood Tests:

   • CMS emphasizes that when ordered by a doctor, these tests continue to be covered for patients in place of a more invasive biopsy.
   • It reiterates its commitment to ensuring transplant patients with Medicare can access the coverage, care, and services they need.

Analysis: Differing Perspectives

Articles One & Two:

• Position:
  • Criticize Medicare’s policy as a harmful cost-cutting measure that could compromise patient care and outcomes.
• Evidence:
  • Include statements and concerns from doctors, patients, and transplant experts.
• Emphasis:
  • On the vital role of non-invasive blood tests in early detection and intervention in cases of organ rejection.

Article Three (CMS Statement):

• Position:
  • Defends the policy, asserting no change in coverage and maintaining that patients can still access these tests when medically appropriate.
• Evidence:
  • Details the LCD development process, emphasizing adherence to statutory authority and rules, including a comment and notice period.
• Emphasis:
  • On addressing billing and overutilization issues and ensuring clarity in coverage criteria and billing instructions.

Conclusion:

The conflict between Articles One & Two and Article Three revolves around the perception and portrayal of Medicare’s policy on blood tests for transplant patients. While Articles One and Two view the policy as a detrimental cost-cutting strategy, the CMS statement in Article Three portrays it as a necessary clarification to address billing issues and ensure continued access to medically appropriate tests. The disparate narratives underscore the complexities in healthcare policy, highlighting the tension between cost management and ensuring optimal patient care and outcomes. Effective communication and a transparent decision-making process are crucial to reconciling these divergent perspectives and ensuring that patient care remains the central focus of healthcare policy.