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10 For 10

10 For 10: Top Compliance Stories For the Week Ending August 19, 2023

Welcome to 10 For 10, the podcast which brings you the week’s Top 10 compliance stories in one podcast each week. Tom Fox, the Voice of Compliance brings to you, the compliance professional, the compliance stories you need to be aware of to end your busy week. Sit back, and in 10 minutes hear about the stories every compliance professional should be aware of from the prior week. Every Saturday, 10 For 10 highlights the most important news, insights, and analysis for the compliance professional, all curated by the Voice of Compliance, Tom Fox. Get your weekly filling of compliance stories with 10 for 10, a podcast produced by the Compliance Podcast Network.

·       Ukraine ABC lessons from Afghanistan. (NPR)

·       Paxton allegedly created fake Uber account to engage in corruption.  (Texas Tribune)

·       Inotiv facing FCPA issues around importing monkeys for research. (WSJ)

·       BNSF tries to settle massive data privacy claim.  (Reuters)

·       Federal corruption investigation heating up in Ohio. (Ohio Capital Journal)

·       SEC Whistleblower Program growing pains.  (WSJ)

·       African Development Bank not using ABC funds. (FT)

·       Aide to Madagascar leader arrested for corruption.  (FT)

·       Grupo Aval settles FCPA enforcement action. (WSJ)

·       Health care corruption sweep in China. (South China Morning Post)

You can check out the Daily Compliance News for four curated compliance and ethics related stories each day, here.

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Greetings and Felicitations

Greetings and Felicitations: The Future of Healthcare…Is Now: Part 5 – Down the Road

What is the future of healthcare and when will it arrive? To explore these and similar questions I visited with Dr. Ben Locwin and Scott Endicott in a five-episode podcast series. Over this series we have explored why the future of healthcare is now; gene and cell therapy, the use and misuse of statistics, Hippocrates and modern healthcare and where healthcare will be headed down the road. In this concluding Part 5, we look down the road at the future of healthcare.

The rapid advancement of technology has changed the way we live and work, and it’s also changing the way we receive healthcare. From smaller and smaller silicon wafer chips to quantum computers and micro dosing insulin pumps, technology is becoming more and more prevalent in healthcare.

At the same time, however, this technology poses several potential risks and ethical implications. Data privacy is a major concern, as there have been cases of lost or de-anonymized patient data from electronic health records getting out into the public sphere. AI and machine learning are also being used to collect and predict data, which could lead to further data privacy issues.

Ben and Scott recently discussed the potential risks and benefits of technology and the need for appropriate regulation and oversight to control the future of medical decision making. They also discussed the importance of patient advocacy and self-advocacy, as well as understanding and controlling how data is used.

Taking a counterfactual approach to contemplate the future of healthcare, it’s clear that technology advancements are here to stay. Software as a medical device is an open access point for hackers to get into highly critical medical devices. According to an IBM report, 550 organizations had a data breach between 2022 and 2023, and healthcare organizations had the highest average cost of data breaches at $11 million, up 8% from last year and 50% from a couple of years ago. With malware and ransomware looking to steal data due to the potential financial gain, the loss and risk to patient data from electronic medical and health records is a major concern.

Moore’s Law applies to both good and negative aspects of technology growth. Within 10-20 years, medications will be administered trans-dermally instead of through a bottle, and micronization of diagnostic capabilities will be available. Healthcare services, decisions, and other roles will be available through Amazon-like delivery. AI and ML are becoming more of a buzzword challenge, with many references being made to them in conversations. AI is currently being applied to chat and other spaces but is still five years away from being able to be transformational in medical applications. Genomics data is now accessible for criminal investigations, creating a downside risk. Technology is shrinking and getting faster, with microprocessors being built on five nanometer dies. Computers are beginning to take over for human decision making, with the widespread use of AI being seen in the future.

To ensure that these advancements are used responsibly, appropriate regulation and oversight is key. Ben believes that the human race has a tenacity to revert back if things become too extreme. Scott believes that patient advocacy and self-advocacy will be key to the change that needs to happen. Understanding and controlling how data is used is essential, as well as having more ethicists involved in the industry.

We hope that this blog post has provided you with some practical advice and data-driven insights to help you navigate the world of healthcare technology.

Key Highlights

·      Medical Technology Risks

·      AI in Healthcare

·      Moore’s Law and Medicine

·      Data Privacy and Telemedicine

Resources

Dr. Ben Locwin on LinkedIn

Scott Endicott on LinkedIn

Tom Fox on LinkedIn

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Greetings and Felicitations

Greetings and Felicitations: The Future of Healthcare…Is Now: Part 4 – Exploring Healthcare Trends: QALYs, CRACO and Hippocrates

What is the future of healthcare and when will it arrive? To explore these and similar questions I visited with Dr. Ben Locwin and Scott Endicott in a five-episode podcast series. Over this series we will explore why the future of healthcare is now; gene and cell therapy, the use and misuse of statistics, Hippocrates and modern healthcare and where healthcare will be headed down the road. In this Part 4, we look at some current trends in health care including QALYs, CRACO, and more.

This episode of the podcast explored the emerging health care trends that will impact patients and family caregivers, such as Quality Adjusted Life Years (QALYs), which is a metric used to measure the quality of life; and Clinical Research as a Care Option (CRACO), which is an emergent option for cancer treatment, combining traditional standard of care drugs with cutting-edge therapies. Tom, Ben, and Scott discussed the potential benefits and risks of virtual healthcare, including the ability to access care remotely and the potential for nefarious actors to access sensitive information. They also discussed the importance of advanced directives and the need to consider quality of life versus end of life when making decisions.

They also discussed the potential benefits and risks of virtual healthcare, including the ability to access care remotely and the potential for nefarious actors to access sensitive information. They also discussed the importance of advanced directives and the need to consider quality of life versus end of life when making decisions.

Having an appropriate document in place and giving the decision-making power you want to make that designation is important. Quality of life versus end of life is an important consideration when making decisions. Immunotherapies can extend life, but it is important to consider the quality of life that the individual is seeking. Prostate cancer is a condition that affects many males as they age, and advanced directives are a crucial piece to the end-of-life equation, as they help bring a thread of logic to the sequence of events.

Personalized medicine and healthcare have changed drastically in the last five to seven years. Telemedicine and decentralization of healthcare have made tremendous advancements, particularly in rural areas where access to healthcare is often limited. Telemedicine eliminates the need to physically go to a clinic, reducing the risk of exposure to infectious diseases. However, there is a risk of overprescribing medications due to the ease of telemedicine visits, and there is ambiguity in the data regarding the effectiveness of telemedicine. There is also a risk of data breaches due to the use of telemedicine, which could include personal information and medical histories. Technology is advancing, which could help to overcome some of the barriers of telemedicine.

Making end of life decisions is a difficult process, but it is important to consider the quality of life versus end of life when making decisions. Quality Adjusted Life Years and Clinical Research as a Care Option are emerging health care trends that can help to make these decisions easier. With the advancements in telemedicine, more people have access to healthcare, and it is possible to get a better understanding of the quality of life that an individual is seeking.

Key Highlights

·      Digital Health Benefits and Risks

·      Clinical Research as Care

·      Telemedicine Benefits

·      End of Life Decisions

 Resources

Dr. Ben Locwin on LinkedIn

Scott Endicott on LinkedIn

Tom Fox on LinkedIn

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Greetings and Felicitations

Greetings and Felicitations: The Future of Healthcare…Is Now: Part 3 – The Specifics of Managing Obesity

What is the future of healthcare and when will it arrive? To explore these and similar questions I visited with Dr. Ben Locwin and Scott Endicott in a five-episode podcast series. Over this series we will explore why the future of healthcare is now; gene and cell therapy, the use and misuse of statistics, Hippocrates and modern healthcare and where healthcare will be headed down the road. In this Part 3, we turn to the specifics of managing obesity.

This episode of the podcast discussed the importance of personal behavioral health in managing obesity, which is a crisis in the US. Starting with the FDA’s Rumor Control Initiative to combat misinformation, Tom Fox, Scott Endicott and Ben Locwin discussed the need for critical thinking when evaluating pharmaceutical products, the importance of involving a healthcare provider in the discussion, and the use of telemedicine to manage obesity remotely. They also suggested that digital fitbits can be used to monitor activity and that physicians can use this data to make recommendations.

The FDA has recently released the Rumor Control Initiative to combat misinformation. This initiative encourages people to check the source of the information and cross-check it with reliable sources, and to look beyond the headlines to get full context. Drug companies are required to list potential adverse effects of treatments, so it’s important to consider the benefits and risks of treatments together. It’s also important to note that people spread misinformation for various reasons, such as wanting to protect those they care about or feeling connected.

Randomized clinical trials are required for all licensed and marketed pharmaceutical treatments. Hypothesis testing, confidence intervals, and analysis of variance are used to evaluate the efficacy of a drug compared to a placebo. Tom suggested that a physician can track a patient’s activity with a digital fitbit and make recommendations during the patient’s 30 days of a month.

It is important to apply critical thinking and use common sense when evaluating pharmaceutical products. Pharmaceutical products are subject to advertising and branding, which can be difficult to evaluate. Pharmaceutical companies used to employ detailers to provide information to healthcare providers and try to get them to prescribe their product, but now they can buy television time to directly advertise to patients. There is a concern that patients may not have the knowledge to understand the biochemistry, biological impacts, and toxicology of the drugs they are taking, so it’s important to have a trusted healthcare advisor and provider to help interpret the data.

Key Highlights

·      Statistics in Healthcare

·      Managing Obesity Remotely

·      Obesity and Behavioral Health

·      Pharmaceutical Advertising

 Resources

Dr. Ben Locwin on LinkedIn

Scott Endicott on LinkedIn

Tom Fox on LinkedIn

Categories
Greetings and Felicitations

Greetings and Felicitations: The Future of Healthcare…Is Now: Part 2- Revolutionizing Healthcare: Personalized Medicine

What is the future of healthcare and when will it arrive? To explore these and similar questions I visited with Dr. Ben Locwin and Scott Endicott in a five-episode podcast series. Over this series we will explore why the future of healthcare is now; gene and cell therapy, the use and misuse of statistics, Hippocrates and modern healthcare and where healthcare will be headed down the road. In this Part 2, we consider personalized medicine.

The use of personalized medicine, such as cell therapies, gene therapies, and digital therapeutics, is revolutionizing the healthcare industry. In this Part 2 of a special five-part series, Tom Fox, Ben Locwin, and Scott discussed the changes to regulatory pathways and expanded access programs to speed up the approval process for drugs and treatments, as well as the long-term risks associated with taking certain drugs. They also provided advice on how to engage with them on the topics discussed, such as using LinkedIn and Google Search, and concluded the episode by inviting listeners to join them for their next episode. This podcast episode provides an insightful look into the future of personalized medicine and the potential risks and benefits associated with it.

Digital therapeutics, for example, have enabled the ability to measure and install a pump that replicates the functions of the pancreas in real time. Regulatory pathways for device and diagnostic approvals have been simplified and expectations and standards have been shifted. Expanded access programs have been created to allow access to treatments between the end of a clinical study and formal approval. These programs have been especially beneficial for rare disease patients and pediatric patients, as well as late stage oncology patients. Advocacy groups have successfully lobbied for access to treatments for MS and other rare diseases. Risk-benefit utility curves can be used to understand the implications of healthcare decisions.

Personalized medicine is defined as medical therapies that are designed specifically for each individual patient to whom they’ll be administered. An example of personalized medicine is personalized dosing of warfarin, which could prevent 17,000 strokes in the United States annually and avoid 43,000 emergency room visits. Cell therapies, such as Chimeric antigen Receptor T cell Therapy (Car T), are personalized using either a donor or the patient’s own blood. Gene therapies are also used in personalized medicine. Supply chain, as it is currently understood, may well no longer  exist in ten years from now and instead it will look a lot more like a disc that is going to be placed into a personalized sort of therapeutic pump that’s attached to your body. Insulin delivery has become extremely personal, used to be broad based, and required separate measurements of blood sugars and titrating a dose based on that. Dexcom has been providing personalized medicine for a number of years.

Personalized medicine is revolutionizing the healthcare industry, and it is important to understand the long-term risks associated with taking certain drugs. It is also important to understand the regulatory pathways and expanded access programs that have been created to speed up the approval process for these drugs and treatments. With the right resources and guidance, individuals can make informed decisions about their healthcare and take advantage of the many benefits that personalized medicine has to offer.

Key Highlights

·      Cell and gene therapy

·      Personalized medicine

·      Risk-benefit utility

Resources

Dr. Ben Locwin on LinkedIn

Scott Endicott on LinkedIn

Tom Fox on LinkedIn

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Greetings and Felicitations

Greetings and Felicitations: The Future of Healthcare…Is Now: Part 1- Unlocking Healthcare: Passion & Patience

What is the future of healthcare and when will it arrive? To explore these and similar questions I visited with Dr. Ben Locwin and Scott Endicott in a five-episode podcast series. Over this series we will explore why the future of healthcare is now; gene and cell therapy, the use and misuse of statistics, Hippocrates and modern healthcare and where healthcare will be headed down the road. In this Part 1, we explore why the future of healthcare is now.

The global response to the COVID-19 pandemic has largely been a remarkable success, and healthcare workers have shown incredible dedication and passion in the face of extraordinary circumstances. In Part 1, guests Ben Locwin and Scott Endicott explained the need for a stronger advocacy position for healthcare, the challenges of the healthcare industry, and the importance of passion and patience in the industry. They highlighted the need for shared decision making between clinicians and patients, and the opportunities for startups to get products to market faster.

Healthcare is an ever-changing landscape, and regulatory favorability is allowing for faster approval of products to market. New therapies are already emergent and available for use, and healthcare is becoming intensely personal. The goal of the podcast series is to provide options for patients and clinicians to advocate for better healthcare.

Healthcare can be a scary place, even with the opportunity for return to health. That’s why shared decision making is an important approach. This is where the clinician and patient share the best available evidence when faced with the task of making decisions. Patients are supported to consider their options and achieve their informed preferences, and it is the most ethically appropriate pathway.

Startups in the healthcare industry have a long and difficult regulatory approval process, taking 5-7 years at best. Investment, passion, belief, and engagement are essential for success in the healthcare industry. It can be daunting to take on such a challenge, but it is worth it to bring innovative solutions to the healthcare market.

To sum up, the global response to the COVID-19 pandemic has shown that passion and dedication are essential for success in the healthcare industry. Additionally, shared decision making is an important approach to ensure that the best available evidence is shared between clinicians and patients. Finally, startups in the healthcare industry require investment, passion, belief, and engagement to get products to market faster.

Key Highlights

·      Passion in Healthcare

·      Biotech Investment

·      COVID Healthcare Impact

·      Shared Decision Making

Resources

Dr. Ben Locwin on LinkedIn

Scott Endicott on LinkedIn

Tom Fox on LinkedIn

Categories
Compliance and AI

Compliance and AI – Vinay Kumar on the Business Uses for AI in Regulated Industries

In this episode, Tom Fox interviews Vinay Kumar, the founder, and CEO of Arya.ai. Vinay discusses the importance of regulations in AI to prevent unethical use in business, including the potential dangers of superintelligence. Vinay emphasizes the need for responsible and ethical use of AI while discussing how Arya.ai simplifies the deployment of responsible and safe AI in the banking, finance, and insurance industries. Vinay also explains how a verticalized AI cloud with observability layers can provide value to the industry by ensuring transparency, auditability, monitoring, and safety of model output to protect customer and company interests.

Don’t miss this informative podcast that will enlighten you on the proper use of AI in business and the importance of regulations.

Key Highlights:

  • ML observability and founding Arya.ai
  • From Stem Research to BFSI: Pivoting AI Development
  • AI solutions for the insurance industry
  • Importance of ML observability layer
  • Challenges of Health Claims Automation
  • Ethical Concerns in AI Usage for Business

 Key Quote:

“We thought we were solving a fundamental problem, which is simplifying the information interaction problem, and that can only happen when I spend my time more effectively on the topic rather than solving these on-ground tasks.”

Resources

Vinay Kumar on LinkedIn

Arya.ai

Tom Fox

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Compliance Man Chooses the Target

Compliance Man Takes a EuroTrip – Andrea Cardoso on Healthcare

Compliance Man is back for a new season! Get ready for a EuroTrip with Tom Fox and Tim Khasanov-Batirov on their hit podcast, Compliance Man! Join Tom Tim as they chat with Andrea Cardoso, a compliance officer in the medical devices industry, about healthcare compliance in Europe. In their Euro trip series, they explore hot topics and share best practices, focusing on interactions with healthcare professionals and fair market value. With years of experience, Andrea highlights the importance of transparency and following certain principles to ensure compliance. Listen as they discuss the challenges of maintaining professionalism in the healthcare industry, understanding different rules and limitations in each country, and implementing effective compliance programs in multiple markets. Don’t miss out on the insightful tips and suggestions, and reach out to be part of the discussion. Tune in to the Compliance Man podcast for valuable insights and expert advice.

Key Highlights:

  • Healthcare Compliance in Europe
  • Compliance with event expenses and regulations in healthcare
  • Compliance with HCP rules in Europe
  • Video Calls and Challenges in Healthcare Industry
  • Empowering Teams for Informed Decision Making
  • What a difference 300 meters can make

 Resources

Andrea Cardoso on LinkedIn

Tim Khasanov-Batirov on LinkedIn

Tom Fox

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Innovation in Compliance

Exiger’s Fight to Secure Supply Chains: Spotlight on Healthcare


Welcome to a podcast series on the fight to secure Supply Chains, through cross-industry innovation. This series is sponsored by Exiger. In this series, we will explore the ongoing efforts of Exiger to lead the discussion and enhancement of Supply Chain Risk Management.
Over this series, I visit with Erika Peters, Senior Vice President and Global Head of Third Party & Supply Chain Risk Management;  Tim Stone, Senior Director, Supply Chain Risk Management for Exiger Federal Solutions; Kim Lee, Director who focuses on risk and compliance; Nick Wildgoose, a Consultant at Exiger; Skyler Chi, Director and Deputy Head of Supply Chain and Third-Party Risk Management;  Andrew Lehmann, Associate Director at Exiger; Jennifer Nestor, Vice President at Exiger, Americas and Public Sector; Theresa Campobasso, Senior Director for Defense Programs; Dan Banes President of Commercial Technology, and Mark Henderson, Director of Solution Design Lead.
In this episode 1, we discuss Supply Chain issues in the healthcare industry with Erika Peters and Tim Stone. Highlights of this podcast include:

  • Key challenges for Supply Chain Risk Management in healthcare;
  • Lessons learned from Covid-19 on Supply Chain in healthcare; and
  • The evolving areas for Supply Chain Risk Management in healthcare.

Resources
Erika Peters Profile
Tim Stone Profile
Exiger Website
Exiger’s Supply Chain Explorer

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Blog

Exiger’s Fight to Secure Supply Chains: Spotlight on Healthcare

Welcome to a blog post series on Exiger’s fight to secure supply chains, sponsored by Exiger LLC. In this series, we will explore the ongoing efforts of Exiger to lead the discussion and enhancement of Supply Chain Risk Management. In Episode 1, I visit with Erika Peters, a Senior Vice President (SVP) with close to two decades of experience working across the financial, corporate, and government industry, and focus on the firm’s supply chain and third-party risk management practices, and Tim Stone, Senior Director, Supply Chain Risk Management, for Exiger Federal Solutions. We discuss supply chain issues in the healthcare industry, including hospitals, life sciences, pharmaceuticals, medical devices, and medical services.
We began with critical supply chain risk management challenges in the healthcare industry. Peters said the “way I think about the healthcare sector and how it differentiates from the other sectors is that the ultimate risk is trying to mitigate fatalities. This means thinking about the third parties that healthcare companies must work with and then their supply chain makes it one of the most extremely critical industries to be thinking about. In the current post-pandemic era, it is one of the timeliest topics. Equally important is that if you must switch out a key vendor, the entire process can take between 12-18 months, putting your organization in a bind. This means you need to put a rigorous process in place and then follow that process.”
Stone noted key lessons learned on healthcare industry supply chain issues from the pandemic. He stated that the federal government created a Joint Acquisition Task Force in the Department of Defense (DoD) during the pandemic. This was an interagency push to source products across various pandemic-related areas like therapies, vaccines, ingredients, testing, materials and equipment, personal equipment, and even items such as no-touch thermometers. The task force illuminated dozens of product areas across those different sectors, then used market intelligence tools to identify companies in each industry. Further, they used modeling to estimate production capacity and entered information into the Exiger software product DDIQ to risk-rank based upon these and other inputs.
This led to the finding of supply chain fragility. This is because many components in the healthcare supply chain come from state-owned enterprises, and many of these are from China. Even when the team began to focus on migrating to India, it turned out that many underlying components came from China. Another problem discovered was the concentration of raw goods and manufacturers. Stone noted, “we saw otherwise obscure examples of concentration risks arise during COVID that you had never thought about before. In Malaysia, for example, we realized it was a top producer of nitro gloves that owns about 65% of the market. This led to COVID-driven disruptions, which impacted our ability to get nitro gloves. This was the way the world turned and focused on supply chains and where goods are ultimately sourced.” Just-in-time supply chains saw similar if not more disruptions as well.
We then turned to how the healthcare industry supply chain can improve its approach to managing risk. Here Peters noted there were two key areas. The first is programmatic, and the second involves a technological solution. Companies need to create a genuinely risk-based program, for instance, looking at entities that will cause an operating room to shut down or prohibit a company from getting materials required for medicines. These critical entities need to have the most in-depth due diligence; taking that strategic risk appetite and having it trickled down to the tactical level is an important way of making sure that the people at the bottom who are doing the actual work that they are hitting the right risk lens that the company wants to take.
The other piece is to have technology in place to facilitate this and that “we need to improve on that technology.” She noted, “we get to this higher level of more of a predictive posture, which is the golden standard where we need to be. We need to have these teams looking at their risk and bringing it into one view of this entity, especially these critical ones.” It looks at a wide variety of risks, from legal/regulatory to geopolitical to operational. It is doing so quickly and efficiently so the front-line supply chain professionals can make decisions for their organizations’ long-term care and health.
Stone concluded that down the road, supply chain professionals in the healthcare sector “can improve the bottom line, through greater fluidity, greater understanding of their supply chains, greater ability to on the fly to gauge the credibility of vendors, and have that due diligence information at their fingertips through technology.” It will also help avoid a lot of fraud, waste, and abuse and create a more well-oiled machine from a supply chain perspective.
Join us tomorrow when we spotlight the manufacturing and consumer markets.
Resources
Erika Peters Profile
Tim Stone Profile
Exiger Website
Exiger’s Supply Chain Explorer