Category:

Self Care

Humana and IBM Watson Health are collaborating to provide the insurer’s Employer Group members with access to a conversational AI solution.

The solution, called the IBM Watson Assistant for Health Benefits, is an AI-enabled, cloud-based virtual assistant. The AI assistant gives users information about member benefits, coverage, claims, referrals and healthcare cost estimates, said an IBM Watson Health spokeswomen, who declined to be named, in an email.

The solution will be made available to all members of the Louisville, Kentucky-based payer’s Employer Group, which includes 1.3 million medical and 1.8 million dental members.

IBM is not the only tech giant that is using AI chatbot technology to make inroads in healthcare. Microsoft, for example, has been popular among insurers and providers alike, launching triage chatbots and other AI technology. For IBM, it also affords the chance to prove its value in offering AI services dedicated to healthcare — it stumbled in 2017 in its loftier vision to use the technology to one day revolutionize cancer care and more recently in 2019 when it abandoned the AI product meant to speed up drug discovery.

But Humana believes that IBM Watson Health’s AI assistant will provide several benefits to health plan members, said a spokesman for the insurer, who declined to be named, in an email. Specifically, it will provide personalized answers to questions from members.

“Customers want us to make it easy, meet on their terms, and save them time,” he said. “The Watson [Assistant for Health Benefits] offers immediate answers to the majority of customer questions without [them] having to call in for help.”

In addition, the solution can aid in the move toward price transparency, which is now a part of federal regulations for insurers. Beginning Jan. 1, 2023, insurers must disclose negotiated rates and provide estimates of patient out-of-pocket costs for 500 services and items per a federal rule finalized in October. Payers must make that information publicly available for all items and services starting Jan. 1, 2024.

The IBM AI assistant’s cost transparency tool, which uses historical claims and provider data to calculate cost estimates for members, will help the insurer comply with the federal rule.

This is not the first time Humana and Armonk, New York-based IBM Watson Health have partnered on AI technology. The companies developed the Provider Services Conversational Voice Agent with Watson, which was made available to healthcare providers in 2019.

“Given the success, both parties see considerable value in investing in the co-creation of a new, cloud-native, healthcare-specific product,” said the Humana spokesman. “IBM has the technical experience to optimize the AI platform and Humana has the business expertise to bring forward the desired customer experiences.”

The collaboration between the payer and technology company is coming as the use of AI chatbots is soaring.

Though interest in AI-powered digital assistants was growing prior to 2020, the Covid-19 pandemic accelerated its use. Companies, like chatbot and voice bot company Syllable, found themselves overwhelmed by demand, and health systems like Cincinnati Children’s Hospital Medical Center and Springfield, Illinois-based Memorial Health System quickly developed and deployed the technology.

AI-powered chatbot use is expected to grow and continue to shape healthcare in 2021.

Photo: Gerasimov174, Getty Images

0 comment
0 FacebookTwitterPinterestEmail

Digital health startup Sharecare plans to go public through a merger with a special purpose acquisition company. Photo credit: Sharecare

Digital health startup Sharecare confirmed reports that it plans to go public through a merger with a blank-check company. The Atlanta-based startup plans to merge with a special-purpose acquisition company created by Alan Mnuchin, CEO of Falcon Capital and brother of former Treasury Secretary Steve Mnuchin.

The deal would value Sharecare at $3.9 billion and add $400 million to its balance sheet. It plans to use the funds to  grow its business, build out its salesforce, and help pay for its recent acquisition of healthcare artificial intelligence startup Doc.AI.

Sharecare was founded in 2012 WebMD creator Jeff Arnold and TV personality Dr. Mehmet Oz. Started as a health and wellness social media platform, the company later began working with heath plans with its acquisition of Healthways’ population health services business in 2016. It has raised $450 million in funding to date.

“We started Sharecare to leverage innovations in consumer technology – specifically the smartphone – to create a frictionless experience that engages people across the dynamic continuum of their healthcare needs,” Arnold said in a news release. “By integrating fragmented point solutions and bringing together stakeholders across the healthcare ecosystem into one connected virtual care platform, we believe that Sharecare is uniquely positioned to transform the way people access, providers deliver, and employers and health plans administer high quality, cost efficient healthcare.”

Blank-check company Falcon Capital Acquisition Corp. will bring $345 million of cash held in a trust to the deal. Private investors including Koch Strategic Platforms, Baron Capital Group, Eldridge, Woodline Partners LP and Digital Alpha will contribute $425 million in a private investment in public equity (PIPE).

Anthem will also make a direct investment into Sharecare for an undisclosed amount after its chief digital officer, Rajeev Ronanki, recently joined Sharecare’s board of directors. 

“Through this relationship, we will leverage human-centered design and digital technologies, including artificial intelligence, that increase consumer engagement, deliver more affordable healthcare, and achieve better health outcomes through services such as next generation personalized healthcare concierge and advocacy services,” Ronanki said in a news release.

After the acquisition closes, Falcon will own roughly 20% of the company. Mnuchin and Jeff Sagansky, an independent director of Falcon, will join Sharecare’s board.

Sharecare has a hodgepodge of features, from pharmacy discount cards to a smoking cessation app to a tool that’s supposed to detect a user’s stress levels from listening to their voice. So far, the lion’s share of the company’s business is  its work with health plans, which are expected to bring in more than half of its revenue for 2021, an estimated $227 million, according to the company’s investor presentation.

For example, Blue Cross and Blue Shield of Arizona began offering the app to its members last year, including rewarding them for tracking their steps. Users are also instructed to answer a lengthy survey for suggestions to improve their health. Some of Sharecare’s other customers include Anthem, Centene, Humana, Walmart and StateFarm.

Another portion of the Sharecare’s business is focused on offering solutions to payers and clinicians, which brought in roughly $80 million last year. For example, it acquired claims review company WhiteHatAI last year, and it also acquired medical records company BACTES, which it rebranded as Sharecare Health Data Services.

Sharecare also has an advertising business, which brought in roughly $56 million last year. Controversially, that included sponsored health advice in Q&As; the company offers condition-specific marketing to pharmaceutical companies and touts its “real-time health profiling engine” in investor slides. But it cannot target ads to users who access the app through their insurance, only those who download it for free, according to its privacy policy.

In the last three years, Sharecare’s revenue has declined slightly, from $347 million in 2017 to $340 million in 2019. Its expected revenue for 2020 is $330 million, with the company attributing the decrease to reduced physician visits and fewer visits at its in-person diabetes clinics, according to an investor presentation.

It reported a $40 million net loss in 2019, compared to a $55 million net loss in 2018.

Still, the company said it expects to bring in $512 million in revenue in 2022, and has “multiple paths” to more than $1 billion in medium-term revenue.

The deal is expected to close next quarter, with Sharecare trading on Nasdaq under the ticker “SHCR.”

0 comment
0 FacebookTwitterPinterestEmail

The Covid-19 pandemic spurred the use of technology, but with growing use comes new challenges.

Southfield, Michigan-based Beaumont Health experienced this firsthand at the end of January, when an unknown user took advantage of an Epic scheduling tool vulnerability. But the incident served as a teachable moment, with the system quickly working to safeguard its vaccine scheduling process, said Beaumont Health Chief Information Officer Hans Keil in a phone interview.

The user publicly shared a link to the scheduling module for the clinic providing Covid-19 vaccines. This allowed 2,700 people to register for an unauthorized vaccine appointment, all of which had to be canceled.

Keil believes that the high level of demand for Covid-19 vaccine is what ultimately led to this incident.

“We had challenges with demand,” he said. “We had to triple our server capacity to be able to support the public and their high interest in getting vaccinated.”

When the vaccine rollout began, Beaumont was leveraging technology already available via its Epic EHR system. It had previously used this technology to schedule influenza vaccinations and conduct serology testing last April.

But the Epic system did not have the ability to send out randomized invitations for vaccinations, Keil said. It was important for the health system to be able to randomize that process to ensure it was administering the vaccine equitably. So, Beaumont set up that capability themselves and improved its server capacity to field the high level of demand. But that still left a gap in the process within the Epic EHR.

The vaccination scheduling process was running smoothly until the unknown user found a way to exploit that gap, short-circuit the registration and go straight to the scheduling tool, Keil said.

It was a sudden spike in traffic that alerted the health system’s IT team to the breach. The health system shut down its Covid-19 vaccination registration and scheduling services, for close to 24 hours.

Now that nearly two weeks have passed since the incident was discovered and addressed, Beaumont is focused on preventing this from happening again.

In the short term, the health system is monitoring its IT traffic and making sure every pathway coming through is legitimate, said Keil.

In addition, Epic now offers the capability to randomize vaccination invitations within their EHR. Going forward, the health system will use that capability as well as other enhancements that Epic has made to make sure it is “one individual, one ticket, one opportunity to schedule,” said Keil.

Keil does not envision any further IT issues arising in scheduling upcoming Covid-19 vaccinations. But high demand remains a concern.

“We just need to make sure that we maintain the integrity of this process and we be as fair as possible,” he said. “These tools, these platforms were never meant for this kind of demand. Epic didn’t think about that way, we didn’t think about it that way. But it’s different now.”

In some ways, the pandemic has sharpened the focus of the health system’s IT team.

Beyond the rollout, Keil and his team are thinking about how to help get the system’s surgery volumes up to help with financial recovery. This will include creating end-to-end experiences around surgery services and increasing the level of digital engagement among patients.

“You can get spread thin on lots of priorities,” Keil said. “This [public health crisis] makes it a lot more crystal clear as to what’s most important…to make a difference for the experience of patients and the financial health of the system.”

Photo: bsd555, Getty Images

0 comment
0 FacebookTwitterPinterestEmail

Insightin Health, a company that offers payers a personalized member engagement platform, has raised $12 million in a Series A funding round.

The round was co-led by the Blue Venture Fund — a collaboration between Blue Cross Blue Shield companies, the Blue Cross Blue Shield Association and Sandbox — and healthcare growth equity fund Blue Heron Capital.

Insightin Health plans to use the new funds to scale its proprietary inGAGE platform, which is designed to help payers retain and engage their members, said Enam Noor, CEO of Insightin Health, in an email.

The platform applies natural language processing to clinical information and social determinants of health and then generates an algorithm for care management and retention for each member, he explained.

“The AI-driven approach and machine learning algorithm connects the dots for all of the data sources and aggregates the trends for predictive outcomes,” he said. “[The platform makes] recommendations for every touchpoint of member communications and activities.”

Currently, the platform has aggregated data for more than 5 million people.

Scaling the inGAGE platform will allow Insightin Health to bring in new clients and provide new tools within the platform for existing customers.

“[Blue Venture Fund is] committed as an organization to improve the health system, and we feel a solution like Insightin Health takes great strides in getting us there,” said Binoy Bhansali, managing director of the Blue Venture Fund, in a news release. “Their ability to leverage data strategically elevates Medicare Advantage and Managed Medicaid plans’ abilities to improve quality, reduce costs, and drive growth and retention by better engaging members.”

Other investors in the funding round included Health Catalyst Capital, Revolution’s Rise of the Rest fund and SaaS Ventures.

The market for personalized consumer engagement platforms is crowded, with companies like Zipari, Welltok and Health Mine all jostling for market share. In addition, large enterprise companies are moving into the healthcare space, such as SalesForce and Microsoft, Noor said.

But Insightin Health sets itself apart by being the only single platform that is able to aggregate all data points for both structured and unstructured data into one ecosystem, he added.

In contrast to many companies that have suffered amid the Covid-19 pandemic, Insightin Health has fared well.

Though Noor declined to share the company’s current valuation, he said Insightin Health experienced 170% revenue growth year-over-year from 2019 to 2020. The company is aiming for similar growth this year.

The company’s growth during the pandemic is partly due to the fact that Insightin Health developed tools focused on the senior population in March 2020, Noor said. These tools gather data on Medicare and Medicaid beneficiaries and then use machine learning to help payers determine patient risk factors.

Photo: StockFinland, Getty Images

0 comment
0 FacebookTwitterPinterestEmail

Question mark heap on table concept for confusion,

The MedCity INVEST conference, scheduled for April 19-23, is offering new ways for healthcare startups to connect with investors at the online event. Ask the Investor sessions will provide a way for startups to get insights on investment strategy and to pose questions about funding and more.

Ellen Herlacher Principal, LRV Health, is one of a handful of investors taking part in these sessions. She will be joined by Dennis Depenbusch, Director New Ventures, BCBS Kansas and president of Mid-America Healthcare Investors Network (MHIN) and Austin Duke, Senior Venture Associate, UnityPoint Health Ventures.

Ellen Herlacher, LRVHealth

Although registration to INVEST is free, startups will be asked to pay $99 to participate in Ask the Investor sessions.  Each virtual meeting will include one investor and last for 45 minutes. Following the investor’s presentation on their investment strategy and area of interest, startups will be asked to provide a 1-minute company overview. There will be an opportunity for Q&A. Investors will receive executive summaries for each startup with contact information.

Space is limited to 10 startups per meeting. Please register here.

Herlacher said she decided to participate in the Ask the Investor session in part because the last year has been so tough on entrepreneurs. The lack of in-person meetings in the past year has meant fewer opportunities for them to network and meet potential partners, customer, employees, or investors.

“I can relate because, as an investor, I’ve missed being able to have chance encounters and thoughtful conversations with talented entrepreneurs, too. I’m really looking forward to the Ask the Investor session at INVEST because it will help fill that void a little bit.”

In response to emailed questions, Herlacher noted that LRVHealth is a venture platform that invests exclusively in early stage digital health companies.

“Our investment dollars are 100% strategic, which is to say that our investors are a mix of healthcare systems, payers, and  large healthcare IT vendors. We draw heavily from their perspectives as well as from our collective experiences as healthcare operators to invest in companies that improve the delivery and administration of healthcare and make people healthier.”

Asked what kinds of criteria LRVHealth considers when deciding whether to work with a startup, Herlacher noted that strategic alignment with the investment themes the firm has developed through close counsel with its network, based on their current and future priorities, is the most important consideration.

“On top of that, I also look for thing like quality and aptitude of the team, size of the market and competitive dynamics, business model, and go-to-market strategy.”

Herlacher said healthcare startups should work with LRVHealth because the firm is interested in developing deep and meaningful partnerships that are backed by industry experience and a network of healthcare leaders, decision makers, and buyers.

“We have a track record of success that extends over two decades.”

Photo: bernie_photo, Getty Images

0 comment
0 FacebookTwitterPinterestEmail

Even as the novel coronavirus was raging in the U.S. last year, providers were concurrently fighting a different scourge: hackers. 

Several major providers experienced IT incidents in 2020, including the 26-hospital Universal Health Services and University of Vermont Medical Center. Last week, Pittsburgh-based UPMC and Omaha-based Nebraska Medicine announced that they too are on the list.

It’s not just providers who are targets.

Charles J. Hilton & Associates P.C. — which provides billing-related legal services to UPMC — alerted the health system that the personal data of more than 36,000 of its patients may have been compromised due to an information security breach. The company determined that hackers had logged into several of its email accounts between April 1 and June 25. The accounts contained various types of information, including Social Security numbers, dates of birth, bank or financial account numbers, insurance information as well as information related to diagnoses, treatments and medications.

The incident did not affect UPMC’s EHR or other computer systems, and there is no evidence that the data was misused, according to a notice issued by UPMC. Charles J. Hilton & Associates is offering credit monitoring and identity protection services to all individuals whose data was impacted.

Similarly, Nebraska Medicine and the University of Nebraska Medical Center discovered that an unauthorized party gained access to its shared network between Aug. 27 and Sept. 20, 2020. The unauthorized party deployed malware and acquired copies of some patient and employee information, including names, addresses, insurance information and clinical information. The Social Security numbers of some patients were also impacted.

In all, the data breach affected approximately 219,000 individuals.

The unauthorized party did not gain access to Nebraska Medicine and University of Nebraska Medical Center’s EHR app, and there is no evidence that any of the impacted data has been used fraudulently, the organizations said. But they are providing complimentary credit monitoring and identity theft protection services to all individuals whose Social Security numbers or driver’s license numbers were accessed.

“It is an unfortunate reality of our digital age that ‘bad actors’ are a constant threat to healthcare,” said Nebraska Medicine CEO Dr. James Linder in a news release. “Every major healthcare entity faces the same challenge, and we have seen many healthcare systems, businesses, and government agencies that were impacted by a data security attack in the past six months.”

The organizations will review their networks for unauthorized activity and work to strengthen their controls, said University of Nebraska Medical Center Chancellor Dr. Jeffrey P. Gold.

As providers enter 2021, data security will remain top-of-mind as they are the most common targets for cyber criminals attacking the healthcare industry.

From January to October last year, 513 healthcare organizations reported a breach of 500-plus patient records to the Department of Health and Human Services. Of these reported breaches, 404 occurred among providers, affecting approximately 13.5 million patients.

The threat of cyber attacks targeting the healthcare industry is on the federal government’s radar as well.

Three federal agencies released a joint notice in October 2020 warning of a credible cybercrime threat to U.S. providers and asking the industry to remain vigilant.

Photo: anyaberkut, Getty Images

0 comment
0 FacebookTwitterPinterestEmail

3d printing human body. 3d printed implants on white background.

Back in the 1970s, there was a television show called “The Six-Million-Dollar Man” about a fictional astronaut severely injured in a test crash, and then having several body parts replaced by robotics. The show’s opening narration promised that he would be “better than he was before. Better. Faster. Stronger.”

Life is now imitating art, and then some. 3D printers are currently being used to construct not only customized prosthetics for patients in need, but a wide variety of other medical items — foremost among them tissues and organoids, as well as surgical models and tools. It is estimated that 13 percent of 3D printing revenue comes courtesy of the medical field, and that some $3.19 billion will be spent on technology in that sector by 2025. That’s over $2 billion more than in 2018 ($1.13 billion), a compound annual growth rate (CAGR) of 15.89 percent.

There are many reasons for this uptick, not the least of which are that these items can be produced quickly and inexpensively. But there is none bigger than the ever-increasing demand for prosthetics. Some 30 million people around the world, including 1.9 million in the U.S., are in need of such devices, and as of 2018 only 20 percent of them had been provided for.

Factor in other devices and “an aging population with a consequent increase in demand for personalized treatment” — as noted by Tim Deng, Principal Medical Devices Analyst at GlobalData, in a report on the website Express Healthcare — and the overwhelming need becomes that much clearer.

So too are the benefits of meeting that need. Better, faster, stronger? Well, that part might be a bit of a stretch, at least for now. But certainly it appears that 3D printers are making it possible for patients to be as good, as fast and as strong as they were before illness or injury left them a shell of their former selves.

Serendipity helped galvanize the 3D prosthetics industry. In 2011 an artist named Ivan Owen developed a puppet hand for a steampunk event — i.e., an event where modern technology melds with elements of Victorian-era history and fashion. He circulated a video of his creation, which was seen by Richard Van As, a South African carpenter who, having just lost four fingers in an accident, was looking for a prosthetic hand that would enable him to return to work. The two of them collaborated to construct just such a device, then used a 3D printer to develop another for a five-year-old boy who was born without fingers.

Owen, instead of patenting his invention, elected to open-source it. That led in 2013 to the formation of the nonprofit organization e-NABLE, an online community enabling people to collaborate on the design of 3D prosthetic limbs. Another nonprofit, Limbitless Solutions, came along a year later, with the mission of providing 3D-printed arms for children.

Then there is the startup Unlimited Tomorrow. In 2020, some six years after its founding, the Rhinebeck, N.Y.-based company also rolled out a prosthetic arm courtesy of a 3D printer, while emphasizing its affordability (“as low as $7,995.”) compared to prosthetics produced by other means (over $50,000).

3D printers are getting ever closer to being able to produce organs, and progress is being made on other fronts as well. In 2018, researchers at the University of Utah became the first to produce ligaments and tendons in that fashion, by extracting stem cells from a patient’s body fat, printing them onto a layer of hydrogel, allowing time for the cells to form the required connective tissue outside the body and then implanting it where needed.

This is a particularly important breakthrough, since injuries to tendons and ligaments had in the past proven to be difficult to treat. Most commonly, tissue from cadavers was used, but there was the risk of rejection, or that the connective tissue wouldn’t perform as expected.

In 2019, there was another promising development when a team at Rice University made promising strides toward producing cardiovascular networks and lung-like air sacs through the use of bioprinting technology called “stereolithography apparatus for tissue engineering,” or SLATE. The team hopes to commercialize that technology in the future, which could have obvious benefits for those suffering from heart or lung disease.

Truly there seem to be no bounds to what 3D printers might mean for healthcare. The possibility exists of dental professionals using the technology to create customized dental implants, prosthetics and braces — that printing could be done in-office without long wait times. Once the patient’s teeth have been scanned, their dental treatment will be printed in-office. This allows for a better fit and even time for immediate troubleshooting. Compared to taking a mold and relying on an outside source, this is more convenient for both patients and professionals.

On the other side of the equation, a 3D printer can be used to create customized instruments for use in complex surgeries — and the process can be done far more quickly than is the case by other means. It is also possible to create three-dimensional models of patients’ internal systems before surgical procedures, giving doctors a clear understanding of the challenges they face.

Also of interest is the production of customized medication via 3D printer, a process begun in 2015 to counter the trend toward producing dosages best-suited for white adult men, meaning women and children were receiving more than was necessary. Customizing the dosage, Multiply Labs CEO Fred Paretti told the website 3D Natives, goes a long way toward “highlighting the individuality of each patient, since the error in dosage of certain active ingredients can even lead to the malfunctioning of some treatments.”

The bottom line is that 3D printers will be making an even greater impact on the medical field in the years ahead, as evidenced by the fact that the number of U.S. hospitals featuring the technology grew from three in 2010 to over 100 in 2019. The need is there, and the evolution will certainly only continue. And someday, maybe there really will be a Six-Million-Dollar Man.

Photo: belekekin, Getty Images

0 comment
0 FacebookTwitterPinterestEmail

UPMC Enterprises, the innovation and commercialization arm of Pittsburgh-based UPMC, launched Astrata. The company has developed natural language processing technologies that aim to improve the quality of care.

Astrata’s technologies help payers and providers assess care delivery in accordance with quality measures, like the National Committee for Quality Assurance’s Healthcare Effectiveness Data and Information Set (HEDIS). These measures aim to ensure the delivery of high-quality care and mitigate gaps.

Increasingly, the government and private payers are tying provider compensation to quality measures amid the move toward value-based care.

The company’s technologies can comb through hundreds of millions of clinical notes, and by applying natural language processing, can identify whether a patient has received care that is compliant with quality measures, said Dr. Rebecca Jacobson, president of Astrata, in a phone interview.

“[The platform] is really evaluating all the text across one member or one patient and [then it] says, yes this person is in the denominator, that is, the measure applies to them,” she explained.

Once the platform has determined whether a measure applies to a patient, it then assesses whether the care they received is compliant with that measure.

For example, there is a HEDIS measure that focuses on older women with bone fractures who have not yet received appropriate imaging and treatment. Astrata’s platform is able to analyze clinical notes and pinpoint those patients.

“That’s a true gap,” said Jacobson. “That is someone that the health plan and the provider want to know about because they want to intervene quickly so that they can prevent subsequent morbidity and mortality.”

Further, the platform allows healthcare organizations to conduct year-round monitoring and quality improvement efforts as opposed to the current system, where quality rates for many HEDIS measures can only be determined once a year via a manual process.

Astrata partnered with UPMC Health Plan to develop and validate its technologies. The platform has been used by UPMC and UPMC Health plan for several years.

“Over the last two years, UPMC Health Plan abstractors found they can work up to 38 times faster with the implementation of Astrata’s NLP-assisted tools,” said Diane Holder, president and CEO of UPMC Health Plan, in a news release. “This partnership facilitates a more rapid and accurate flow of thorough, meaningful data between our quality team and our providers.”

With the launch of the spinout, Astrata’s tools are now available in the U.S. market.

The company also plans to increase its workforce by 30% in 2021.

Photo: sdecoret, Getty Images

0 comment
0 FacebookTwitterPinterestEmail

Johnson & Johnson has formally asked the FDA to allow emergency use of its Covid-19 vaccine as the company seeks to add a third option to the U.S. lineup of vaccines for the novel coronavirus.

The application comes a week after J&J released preliminary data showing 66% overall efficacy in a Phase 3 clinical trial. Those results fall short of the efficacy marks of messenger RNA (mRNA) vaccines from Moderna and Pfizer. But the J&J jab offers advantages compared to those vaccines.

Unlike mRNA vaccines, which are given as two doses weeks apart, J&J’s vaccine is a single shot. Also, the J&J vaccine can be kept at refrigerator temperatures. Both the Moderna and Pfizer vaccines must be kept frozen—Pfizer’s at ultra-cold temperatures. They’re then thawed and temporarily stored at refrigerator temperatures before dosing.

J&J’s vaccine storage requirements are the same as those for most vaccines, making it an easier fit vaccine distribution channels already in place. The company said that if authorized, its vaccine will ship using the same cold chain technologies it uses for transporting other medicines. Of the vaccine candidates that have advanced to late-stage testing, J&J’s is the only one given as a single dose.

Before the FDA decides whether to grant emergency use authorization to the J&J vaccine, the pharma giant’s candidate must be evaluated by an independent advisory committee to the agency that will evaluate the clinical data and discuss the efficacy and safety risks of the shot. The vaccines from both Moderna and Pfizer went through the same step. The J&J meeting is scheduled for Feb. 26.

J&J’s vaccine, developed by the company’s Janssen division, employs a version of the virus that causes the common cold. That virus is modified so it does not cause illness. It’s used to deliver to cells a snippet of the genetic code for the spike protein, which is prominent on the surface of the novel coronavirus. The cells of the body read that genetic material and make copies of the spike protein. The immune system responds to those copies by making antibodies that protect against Covid-19.

AdVac is the same platform Janssen used to develop an Ebola vaccine that was approved by the FDA in 2019. The technology is also the foundation of experimental Zika, RSV, and HIV vaccines. J&J said that the safety profile observed with its Covid-19 vaccine was consistent with other experimental vaccines based on AdVac.

J&J evaluated its Covid-19 vaccine in a Phase 3 study enrolling 43,783 patients. The main goal was to show protection from moderate to severe disease. There were geographic differences in efficacy rates. The vaccine candidate was most protective in the U.S., where efficacy was 72%, the company said. In Latin America, efficacy was 66%; in South Africa, it was 57% effective. While those marks fell short of the efficacy rates demonstrated by the Moderna and Pfizer vaccines, cross trial comparisons are tricky. Also, the J&J studies were done when more variants of the novel coronavirus were circulating compared to when the Moderna and Pfizer vaccines were tested.

Paul Stoffels, J&J’s chief scientific officer, said in a prepared statement that the company has vaccines ready to ship immediately upon receiving emergency authorization.

“With our submission to the FDA and our ongoing reviews with other health authorities around the world, we are working with great urgency to make our investigational vaccine available to the public as quickly as possible,” he said.

In addition to the submission to the FDA, J&J is seeking similar authorizations from health agencies in other countries. The company said an application to the European Medicines Agency will be submitted in coming weeks.

Photo: Teka77, Getty Images

0 comment
0 FacebookTwitterPinterestEmail

interoperability

As part of our focus to highlight the confluence of healthcare and legal news, we are featuring interviews with inside counsel at life sciences and other healthcare companies. The first of these interviews features Erich Drotleff, senior counsel for Availity. As the nation’s largest health information network connecting health plans, providers and patients, Availity facilitates over 4 billion clinical, administrative, and financial transactions annually.

At Availity, Drotleff is responsible for negotiating profitable agreements, promoting company growth and profitability, minimizing business risk, ensuring legal compliance, and managing non-lawyer staff. In a phone interview with MedCity News, he weighed in on the role of data-sharing in public health, his path to an in-house role, and the benefits of bonsai gardening.

(This interview has been edited for length and clarity.)

Headshot of Erich DrotleffWhat is the most crucial issue facing health and life sciences lawyers, today, and how would you go about addressing it?

I would have to say information-sharing.

There is so much regulation on data rights, ownership, privacy, and protection that I don’t think we will be able to tap into revolutionary healthcare advancements, such as advanced data analytics using AI and machine learning, until healthcare data can be shared universally.

I know there are serious concerns centered around data privacy and its use that raise many ethical issues. And let us not forget about how truly valuable healthcare data is to hackers; the healthcare sector is one of the largest industries with nonstop data breaches. But for healthcare outcomes to truly advance, we need to have the ability to build a national “data lake” based on inputs from all  stakeholders.

Although the prior administration took steps to lower information blocking, it is still woefully inadequate in providing a meaningful use of and access to necessary healthcare data. Despite the changes initiated by ONC and CMS, too many roadblocks still exist.

The FDA just held a meeting to discuss how to manage data in the development of artificial intelligence for medical devices, and the fact is that you can’t develop anything if everyone’s going to be holding onto their data and saying: “You can’t do anything with it unless it falls within these exact three enumerations under this contract.”

I get that perspective from a company-protection standpoint. And then I get the ethical dilemma from a patient’s perspective — “it’s not your data, it’s my data, it’s about me and my body.” But we need to address it. There’s a lot of discussions around what to do but no solutions, yet. Until we solve this issue there is so much health innovation that’s just going to remain untapped.

What legal industry trends have had the greatest impact on your practice?

When the market crashed in 2008, I was a first-year associate in a small firm. I knew I wanted to go in-house while I started contemplating going to law school and becoming a lawyer as a second career.

However, I didn’t know if many in-house counsel positions were available for someone such as myself, given my prior career as a health plan contracts negotiator.

The 2008 market crash really shook up the legal industry. At law firms, second- and third- to fifth-year associate blood-letting was at an all-time high. Unemployed BigLaw associates were everywhere.

More and more companies were taking their legal work in-house and outsourced less and less once they realized how much they could save for the bottom line by bringing on full-time in-house counsel.

So I guess my first career non-legal work experience combined with a law degree and law firm experience was attractive to many employers seeking to bolster their legal department headcount.

What COVID-19-related change do you think will most impact health and life sciences legal practice, moving forward?

I think telemedicine and remote patient monitoring will continue to grow in both interest and popularity.

But as a result, a significant number of issues will arise. Patient confidentiality, data privacy and data rights, an increase in both use and development of apps, consumer-driven healthcare, and healthcare concierge services. And of course the issue of medical licensing issues across jurisdictions — which state’s medical licensing laws apply?

What is your proudest legal accomplishment (that you’re allowed to talk about)?

I would say my biggest accomplishment since graduating from law school and becoming an attorney was passing the California State Bar the first time!

But as far as during my working career, I took a position in the fall of 2014 at a newly acquired healthcare entity whose parent company had no healthcare legal leadership. My biggest success story was being a one-man legal department and building out the subsidiary so it was aligned with the parent company’s business rules while also making sure the organization was running consistently with necessary healthcare regulations.

They needed a good healthcare attorney with business acumen that understood the landscape as it applied to the healthcare industry, and I was proud to be that person.

What do you wish you could teach your younger self about health and life sciences law, before you went in-house?

That question is a bit difficult to answer since I knew from the moment that I decided to commit to prepping for applying to law school that I wanted to be an in-house counsel and bypass the law firm track.

Unfortunately, most in-house positions require some law firm experience in order to have a well-rounded in-house candidate. So I would tell my younger self to be patient and just realize that all good things take time. Even if that means working at a law firm first before getting that first in-house position.

Having spent years as a health plan contracts manager, what I learned from working at a firm was a better perspective of balancing and managing business risk.

In BigLaw practice, you do everything to ensure your client has slim-to-no risk when they enter into a transaction, but if you continue with that mentality as in-house counsel, you’ll bring the company to a screeching halt. Working at a firm, I developed that necessary understanding that every transaction has a certain risk and applied that to my existing business experience to astutely quantify that risk, evaluate the danger, and advise leadership on the path forward.

There are few business situations that are simply an obvious yes or no, from a risk analysis perspective.

In-between, you can have high return and a high level of risk but low likelihood of a bad outcome. In these cases, you can balance those perspectives and move forward having the ability to tell the organization yes, this does carry a risk, and yes, repercussions could be significant, but the likelihood of it occurring is low.

In my prior career, risk wasn’t on my radar — my marching orders were to negotiate the contracts, close the deals, and move on.

My experience in BigLaw gave me the perspective: “Oh, if this happens, the resulting outcome could be severe.” Most traditional BigLaw attorneys are very risk-averse and carry that mentality into the organization as their in-house counsel.

Historically, an organization’s legal department was often called the “Department of No.” Sometimes they get a bad rap, but I think that’s evolving.

If you could snap your fingers and have the general public understand one thing about health and life sciences, what would it be?

It would have to be for people to understand when they say “don’t let the government take over my healthcare,” that while the two largest health plans in the United States are Medicare and Medicaid, these government programs are administered by private health plans such as Humana, Anthem and United. So when I hear people say they don’t want a nationalized single payer, government-run health system, I have to laugh. Little do they know how Medicare and Medicaid are run.

What three titles would be on your Zoom bookshelf if you were interviewed by CNN?

The three titles would be: “Tribal Leadership” by Dave Logan and John King, Philip Roth’s “The Plot Against America,” and “Cultivating and Growing Bonsai,” because I am a gardener and find it incredibly therapeutic.

“Tribal Leadership” gives a good perspective of high-performing versus low-performing organizations. The authors discuss the different levels of tribal leadership. It’s all about “me,” then it’s all about “us,” and at the higher levels of organizational leadership who “wins” doesn’t matter.

“The Plot Against America” was adapted into a miniseries on HBO, but I read the book first and it had a tremendous impact on me. It’s fiction but pulls on a lot of events that occurred in the 1940s regarding the Jews being persecuted.

In the novel, Charles Lindbergh defeats FDR and serves as the henchman to protect the U.S. from Germany during the 1930s and ’40s. With what’s been going on these past four years, with how the administration allowed white supremacists to get a free pass, it’s an interesting analogy to read this fiction based on real-life events and see how it unfolded.

Bonsai falls in with my passion for gardening and plants; you’ve just got to have the space to keep them outside. If I hadn’t become a lawyer, I would have probably become the owner and operator of a small café, bookstore, garden shop and nursery.

Photo: DrAfter123, Getty Images

0 comment
0 FacebookTwitterPinterestEmail