As a risk management professional, it is important that I understand how my clients’ operations work and then address how best to protect them. Full disclosure, Inside Tracker, 23andMe, Levels, and Apple are not my clients…I am their customer. But I have always been an early adopter of new technologies and only recently noticed how well my curiosity has served me as an insurance broker for many companies like these.

It all started with the Nike Sensor, the Fitbit, and eventually the Apple Watch all tied to apps on my Apple Phone. I have since graduated to monitoring my glucose with Levels in conjunction with a continuous glucose monitor (even though I am not diabetic). Additionally, I also track other biomarkers with Inside Tracker. I have become a tracker junkie. “What gets measured gets managed,” is my motto. The information I glean from these trackers can be useful depending upon what I want to measure; number of steps, exercise minutes, hours of sleep, calories burned, blood pressure, cholesterol, etc. I can then take that information and refine my efforts/outcomes with the hopes of improving my health and longevity.

Over the years, the evolution of wearables and devices measuring and monitoring your body has grown and it has become difficult to keep up. Simultaneously, the growth of telemedicine and digital health companies has exploded. Need a doctor? You can now search for doctors based on availability, location, insurance, reviews, and more. You can see a doctor online for medical advice, prescriptions, and referrals without leaving home. Get physical therapy care from home without copays and office visits. Therapy and counseling, both online, via text, chat or video. These advancements in healthcare technology is exciting and creates greater access for everyone. However, it also comes with concerns and challenges with regards to access, security of personal health data, and prescribing practices to name a few. As of yet, it isn't entirely possible to do every type of visit remotely, after all you still have to go into the office for things like imaging tests and blood work, as well as for diagnoses that require a more hands-on approach. 

Working with companies like these it is critical that we assist them to better understand their exposures and how they can best address them all while protecting their balance sheet. For many, cyber liability, errors and omissions, and data privacy are key exposures. For some, it is medical malpractice liability and helping our clients navigate the various state requirements. Some companies have products that could cause bodily injury to others and we can also provide solutions for those risks.

If we go back to trackers and data, telemedicine and digital health companies must continue to work to help users navigate this data and provide feedback on what needs to be improved or changed, by how much, and by which methods. It’s also important that these companies work with insurance subject matter experts that understand their operations and what risk management strategies and programs can be tailored specifically for their needs.  As both a user buyer of these platforms/services and a risk management specialist, there is not a one size fits all solution. 

Please reach out to our Newfront digital health and telemedicine insurance specialists to discuss your specific insurance needs.

Exploring how the digital world connects end users.

What Do Inside Tracker, 23andMe, Levels, Apple Watch, and Insurance All Have in Common?

Last year right before the world began to shut down, I had the opportunity to attend San Francisco Business Times’ Women Who Lead in Life Sciences event.  I left that event feeling inspired and in awe of all of the amazing women who shared their stories. Who knew how dramatically the world would change and how prominent science would become?

This year’s event was virtual and the theme of Inform, Inspire, Connect was prominent in the two panels of women residing in top roles at life science companies.  Like last year, diversity, equity and inclusion (DEI) continued to be the focus and because this work is a significant part of Newfront’s ethos, we found this event particularly insightful.

The first panel was comprised of female Founders and Funders – academic/science founder, venture capitalist and CEO, all part of Lycia Therapeutics. They discussed forming a company from the science to the funding and then building – with a top-tier CEO and management team. During the build, the stars were aligned as connections were forged from networking with women.

Trailblazers featured panel of women from Five Prime Therapeutics, Allogene, Genentech and Caribou Biosciences. They all agreed that while there is still much work to do with respect to diversity and inclusion, the biotech landscape has improved tremendously in the past few years.

Pay it forward – open doors to help women succeed in leadership roles, especially in fields like engineering, manufacturing and medicine. It’s important for women to be role models for women and men so that men can then support women when those men move into other organizations.

Women’s roles in life science continues to change. There continue to be advances in the C-suite, leadership in research and early development, and improvement in the demographics of clinical studies, with important work in advancing inclusive research.  “No one is surprised that I am a Chief Medical Officer and a woman”, said one panelist.

It is time to be bold. Ask about people’s experiences so they can be included in the conversations about what is needed to further aims of diversity, equity, and inclusion at their organizations. What is preventing women from certain populations from getting a seat at the table? The inclusion of women, people of color, and people from diverse backgrounds isn’t just the right thing to do – it’s good for business.

Having a sponsor is vital for women, especially for women of color. In closed-door meetings, it is critical to have a champion and for C-suite executives or founders to raise their hands or their voices on behalf of women for talent opportunities and career advancement. Women should have a personal “board of directors” to support them throughout their career for advice, professional guidance, networking, etc.

Do not make false promises simply to check a box. Large companies have money and access to hire Chief Diversity Officers and teams. Smaller companies can utilize outside resources from organizations like BIO, company internships and STEM programs such as NexGeneGirls. Biotech companies can learn from each other and champion women to be part of the change.

Last year right before the world began to shut down, I had the opportunity to attend San Francisco Business Times’ Women Who Lead in Life Sciences event.  I left that event feeling inspired and in awe of all of the amazing women who shared their stories. 

Reflecting on Women Who Lead in Life Sciences 2021

Four and a half years following the Brexit referendum, the United Kingdom is now operating in a post-Brexit environment. Due to the loss of passporting rights, Lloyd’s of London, who manages a large portion of foreign clinical trial policies, has transferred all of its European Economic Area (EEA) written business to Lloyd’s Insurance Company S.A.

As part of the deal, the United Kingdom and EU have agreed to recognize each other’s quality standards and inspections of medicines, which means that extra safety checks will not be needed when moving drugs over the border. That should minimize any disruption of supply, including products being tested in clinical trials.

Part VII of the “Financial Services and Markets Act 2000” requires transfer of insurance business to be elected by an insurance business transfer scheme sanctioned by the High Court of England and Wales.

Part VII currently allows for the transfer of insurance business from a regulated UK insurer to an EEA insurer without the need for individual policy replacement or policyholder consent. Part VII also covers Lloyd’s of London business.

It is a common legal mechanism used for restructuring insurance business, in this case allowing for EEA non-life risks to transfer and for EEA non-life risks to be split from non-EEA risks and transferred to Lloyd’s Brussels. Part VII has been used by many other UK insurers in the context of Brexit to transfer EEA insurance policies to European insurers.

The transfer will help ensure EEA policies can be compliantly serviced after Brexit, including the payment of claims. The proposed transfer will not change policy terms and conditions, except that Lloyd’s Brussels will become the insurer and data controller in respect of EEA policies.

The transfer has been carefully designed to ensure that it will not change how policies operate. Life science companies will see no direct administrative change as a result of the transfer.

For UK-led trials, they will require the sponsor or legal representative of a clinical trial to be in the UK or country on an approved country list (this will initially include the EU/EEA countries).  For ongoing trials, the UK will accept a sponsor or legal representative established in the EU/EEA, and no amendment submission to the Medicines & Healthcare Regulatory Agency (MHRA) will be required.

If the sponsor is from the rest of the world, and the legal representative is established in the UK and there are sites elsewhere in the EU/EEA, the sponsor will need to assign an EU/EEA legal representative for these EU/EEA sites.

As always, ABD’s Life Science Practice is available to answer any questions you many have and will continue to provide important updates affecting life science companies.

Four and a half years following the Brexit referendum, the United Kingdom is now operating in a post-Brexit environment. Due to the loss of passporting rights, Lloyd’s of London, who manages a large portion of foreign clinical trial policies, has transferred all of its European Economic Area (EEA) written business to Lloyd’s Insurance Company S.A. […]

Brexit Update and the Impact on Clinical Trials Insurance

As COVID-19 continues to evolve, pharmaceutical, biologic, and medical device companies conducting or planning to conduct clinical trials continue to face challenges that directly impact clinical trials. According to a recent report from Medidata on June 15, 2020, after an initial steep decline in clinical trial activity, both in terms of new patients entering clinical trials and visit rate per test subject for ongoing trials, there is a leveling off of the impact and regional fluctuations. COVID-19 is expected to continue to impact trials, at different times and to varying degrees, worldwide.

ABD’s Life Science Practice continues to closely monitor the impact of COVID-19 on clinical trials and how this may continue to impact clinical trial insurance. As noted in a previous blog from April, companies should ensure that the trial participant’s safety and the integrity of the trial are being maintained and are aligned with FDA and European Medicines Agency (EMA) guidance regarding the conduct of clinical trials during the COVID-19 pandemic.

Rapid and safe implementation of protocol amendments is important to address both site closures and the fact that trial participants no longer receive or have access to the investigational product. Inaccessible sites mean that alternative, remote approaches to drug supply, monitoring study conduct, compliance, patient safety, and data quality are needed. The more trials can be safely “virtualized,” the more likely they will be able to successfully proceed.

Most insurance carriers that provide coverage for clinical trials are aware of the changes in sites to patients’ homes, for example, and are willing to extend coverage to accommodate those changes. It is important to consult with your insurance specialist regarding any material updates to your clinical studies.

The FDA has issued guidance and outlined numerous acceptable mitigations during this time. The FDA regularly updates questions and answers based on major issues sent to clinicaltrialconduct-COVID19@fda.hhs.gov.

Major topics include performing remote “clinic visits” or site monitoring, options for obtaining informed consent, and conducting clinical outcome assessments early. Most recently, the FDA has made its COVID MyStudies app available as an option for obtaining informed consent electronically.

Sponsors should continue to assess ongoing trials and determine the potential risks and necessary mitigations. It is also important to establish and assess procedures for protecting study subjects and adjusting trial processes to account for COVID-19 disruptions.

Sites should continue to communicate with Sponsors/CROs and responsible IRBs/ECs to discuss COVID-19 impacts on a trial. That includes discussing all protocol and process changes with study subjects and obtain informed consent for any modifications requiring new or revised consent.

As always, the ABD Life Science Practice is available to answer any questions you many have and will continue to provide important updates affecting life science companies.

As COVID-19 continues to evolve, pharmaceutical, biologic, and medical device companies conducting or planning to conduct clinical trials continue to face challenges that directly impact clinical trials. According to a recent report from Medidata on June 15, 2020, after an initial steep decline in clinical trial activity, both in terms of new patients entering clinical trials and visit […]

COVID-19 and the Impact on Clinical Trials

As the COVID-19 pandemic unfolds, pharmaceutical, biologic, and medical device companies conducting or planning to conduct clinical trials may be faced with challenges related to quarantines, travel limitations, site closures or access restrictions, infection transmission concerns of site research personnel and study subjects. These companies want to ensure that the trial participant’s safety and the integrity of the trial are being maintained and are aligned with FDA and European Medicines Agency (EMA) guidance regarding the conduct of clinical trials during the COVID-19 pandemic.

Most foreign clinical trial insurance policies do not contain exclusions in relation to COVID-19 (Coronavirus) or any derivative thereof. However, companies should not assume there is coverage because there can be other attributable factors to any claim. As with any potential claim, the facts, circumstances, and policy language must be carefully reviewed in order to provide any specific advice on how coverage may or may not respond.

During this unique time of “shelter-in-place”, the biggest challenge is a trial participant’s access to the hospital/site and vice versa. And with that challenge are the distribution and administrative requirements to complete trial assessments/visits, patient monitoring, particularly in situations where trial participants are being required to self-isolate and the difficulties this will present to effectively provide medical oversight/direct patient care. Additionally, there is the issue of availability and suitability of investigators/trial staff where the pandemic has had an impact on their own personal lives.

The alternative methods introduced to satisfactorily navigate through these challenges will vary from trial to trial, and according to each country. In most instances, this will be achieved via protocol deviation or adopted according to study protocol amendment. The latter regarded by insurance carriers as the preferred method. However, in either scenario, insurance carriers need to be notified to ensure coverage is not prejudiced.

The health and safety of the trial participant should always be paramount, and it is imperative that all participants are fully informed of any changes to their experience as a trial participant, treatment regime, and process, and that the Informed Consent (ICF) is obtained via an ICF addendum. Provided a Sponsor adheres to the COVID-19 guidance and/or the contingent recommendations issued by respective national authorities, and that the trial continues to be conducted in accordance with national legislation, insurance carriers can remain comfortable with the continuation of trials during this pandemic.

From a documentation standpoint, there is the potential issue for countries where coverage is site-specific and home visits are taking place. How the regulatory bodies will approach this remains uncertain today. Take Spain for example, where site specific certificates of insurance are issued – due to privacy laws, insurance carriers would not be able to specify a patient’s home address. So, while the trial is not taking place at the hospital/site, it is the medical team at that specific location carrying out the trial, and therefore in addition to the Sponsor, are covered by the respective clinical trial policy.

COVID-19 has created an unprecedented and constantly developing situation. The Newfront Life Science Practice is available to answer any questions you many have and will continue to provide important updates affecting life science companies.

As the COVID-19 pandemic unfolds, pharmaceutical, biologic, and medical device companies conducting or planning to conduct clinical trials may be faced with challenges related to quarantines, travel limitations, site closures or access restrictions, infection transmission concerns of site research personnel and study subjects. 

Clinical Trials and COVID-19: Challenges and Guidance

Last week, my colleague Dana George and I had the opportunity to attend San Francisco Business Times’ Women Who Lead in Life Sciences event. The event featured a panel of women in top roles at life science companies, who spoke about their personal stories and the most current challenges facing women in the life science industry today. Because diversity, inclusion, and equity are important to us personally and are also a significant part of ABD’s ethos, we found this panel especially insightful.

Women must support other women. The panelists noted that women are less likely to advocate for themselves than their male counterparts, so women in all positions must be willing to lift up and support their women colleagues.

Women should follow their passions. We agreed that women should prioritize pursuing their career goals, even if others tell them they can’t do it. One panelist noted that she used this pushback to her advantage – the element of surprise when she rose to the challenge and succeeded despite obstacles reinforced her confidence in her abilities.

Diversity in life sciences is good for innovation and business growth. The inclusion of women, people of color, and people from diverse backgrounds isn’t just the right thing to do – it’s good for business. Diversity at all levels of business has been shown to lead to greater innovation and customer support.

Women have been shown to negotiate their compensation far less often than men. People in leadership roles should adjust women’s salaries if men are paid more for the same job and same quality work. Updating metrics and increasing visibility surrounding wages, promotions, and management structure is also necessary for ensuring equitable pay.

Women of color, plus-sized women, LGBTQ women, transwomen, and women from unconventional backgrounds are woefully underrepresented in clinical trials. Adjusting trials to include people of all genders, races, ethnicities and backgrounds is essential for ensuring that clinical trials are effective and yield better data.

is the National Life Science Practice Leader at ABD Insurance & Financial Services and leads a team of experienced risk management professionals that service approximately 300 life science clients. She can be reached at cristina.varner@theabdteam.com.

Last week, my colleague Dana George and I had the opportunity to attend San Francisco Business Times’ Women Who Lead in Life Sciences event. The event featured a panel of women in top roles at life science companies, who spoke about their personal stories and the most current challenges facing women in the life science […]

Reflecting on Women Who Lead in Life Sciences

Throughout the last couple of decades, use of prescription opioids has increased dramatically and exploded into a crisis of addiction and litigation affecting millions of Americans every year. Since 2016, over 289 million prescriptions for opioid drugs are written every year and over 1.7 million Americans suffered from chronic opioid abuse in 2017.

High risks associated with abuse and addiction have led to lawsuits against all actors along the supply chain, from manufacturers to physicians. State-level opioid-related lawsuits may surpass tobacco-related lawsuits to become the largest civil litigation settlement agreement in American history.

Insurance carriers have responded to these risks by severely restricting coverage for companies involved in the manufacture or distribution of these products. We’ve observed these changes globally, with all major carriers implementing similar restrictions. Insurance experts expect coverage to be limited to sole individual bodily injury coverage for adverse events related to opioid use, excluding addiction, abuse, diversion, failure to warn, criminal acts and multi-district litigation. Several carriers are adopting policies that categorically exclude coverage for opioids and avoiding this exposure altogether.

Newfront has been working proactively to engage with carriers to obtain the most comprehensive coverage solutions for our clients with opioid products in their portfolio. Due to significant changes in premiums and coverage over the past couple of years, we believe that comprehensive, one-on-one attention is the best way to navigate the challenges associated with opioid products, including solutions that may involve self-insurance.

As opioid addiction continues to swell and as more settlements are reached between states, pharmaceutical companies, distributors, and physicians, the insurance industry’s policies regarding these drugs will continue to evolve. An experienced life science broker with extensive knowledge in this space is necessary to make sense of this changing insurance landscape.

What The Life Science Industry Should Know About The Opioid Crisis

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Articles from Cristina Varner

What Do Inside Tracker, 23andMe, Levels, Apple Watch, and Insurance All Have in Common?

Reflecting on Women Who Lead in Life Sciences 2021

Brexit Update and the Impact on Clinical Trials Insurance

COVID-19 and the Impact on Clinical Trials

Clinical Trials and COVID-19: Challenges and Guidance

Reflecting on Women Who Lead in Life Sciences

What The Life Science Industry Should Know About The Opioid Crisis

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Articles from Cristina Varner

.css-13o7eu2{display:block;}What Do Inside Tracker, 23andMe, Levels, Apple Watch, and Insurance All Have in Common?

Reflecting on Women Who Lead in Life Sciences 2021

Brexit Update and the Impact on Clinical Trials Insurance

COVID-19 and the Impact on Clinical Trials

Clinical Trials and COVID-19: Challenges and Guidance

Reflecting on Women Who Lead in Life Sciences

What The Life Science Industry Should Know About The Opioid Crisis

Newfront for Businesses

Newfront for Employee Benefits

Newfront for Private Clients

Blog ‍

Connect ‍
with ‍
us. ‍

What Do Inside Tracker, 23andMe, Levels, Apple Watch, and Insurance All Have in Common?