2022 Trends and Opportunities for Healthcare and Life Sciences Businesses and Investors
What can Healthcare and Life Sciences businesses and investors anticipate for the healthcare industry in 2022?
We asked our team five direct questions about innovations in healthcare, life sciences, and digital health in the coming year:
What healthcare trends or opportunities are you most excited about?
What do you wish more healthcare innovators knew about their business opportunities?
What emerging or changing risks are you keeping close watch on?
What do you think will be the biggest surprise of 2022?
Anything else you'd like to share about 2022 predictions and trends?
And they did not disappoint! So if you’re already familiar with our expertise and grasp of the industry, then skip ahead to the first question to read what they had to say.
If you’re new to Nixon Gwilt Law
You’ll want to understand why we can so confidently make these annual predictions for our clients (and for the last two years for everyone reading this blog).
NGL lives and breathes healthcare and life sciences innovation. We don’t do anything else. We have hundreds of clients across the spectrum of the industry—care providers, labs, pharmacies, payors, predictive analytics, digital health, medical device and life sciences businesses—and none of them are treading water. These are people and businesses helping people around the world live longer and healthier lives.
In addition to this daily immersion in the waters of innovation, we also advocate for change in the industry with regulatory agencies, policy makers, and thought leaders. We also speak, network, and learn at various conferences throughout the year. And when we’re not doing all of that, we’re mentoring tomorrow’s game-changers through accelerators, incubators, and university lectures. Did I mention several of us are also investors?
Rounding it all out is our podcast on the Slice of Healthcare network called Decoding Healthcare Innovation. We’ve already cracked the Top 100 in Business News on Apple Podcasts, and continue to host today’s key thought leaders in the industry.
All that to say: we’re about as deep in healthcare innovation as you can get. And as we sift through the constant stream of information, we’re able to glean a useful business outlook for the kind of leaders who depend on our insights.
And now you get the benefit of all that experience as we lay out what to look for in 2022.
A final word before we get started: pour yourself a warm beverage and get comfy, because we’ve got a lot to share.
Now let’s get to it.
#1: What healthcare trends or opportunities are you most excited about?
Reema Taneja, our resident telepharmacy expert, says she’s expecting “increased expansion of telepharmacy adoption, as well as increased state regulation of telepharmacy. The chains have begun dipping their feet into exploring telepharmacy services, and I think they will continue to add such services to their offerings. Perhaps some independent pharmacies will also explore similar business models!”
Reema recently returned from speaking about telepharmacy at the American Society for Pharmacy Law Conference in Las Vegas, and she came back even more excited than when she left. After lagging behind telemedicine in development for the past 40 years, telepharmacy is poised to close the gap.
Katherine Bain, aka the Contracts Queen, is all about the data. She says: “Health systems, life science companies, and payers are eager for valuable and usable health care data, including social determinants of health data, to inform their planning, additional value care options, and best in class services.” And Katherine would know, she helps her clients close tens of millions in healthcare data deals each year.
Katherine also says, “The amount of money being invested in the health tech, digital health and telehealth space is only going to go up, because there will be more evidence of its need based on two years of exponential growth.” Up from here? Yes, we’ll take that.
Partner Carrie Nixon seconds that by predicting “increasing adoption by providers of care management services like Remote Patient Monitoring, Behavioral Health Integration, and Chronic Care Management to improve outcomes for patients.”
She also sees “the use of Remote Therapeutic Monitoring (RTM) as a new care management service that incorporates important patient-reported metrics such as pain, mood, and adherence.” Click here to find out how to leverage these new codes in an insightful post by RPM Practice Lead Kaitlyn O’Connor.
Carrie predicts “the rise of Software as a Medical Device (SaMD) as a positive differentiator for software platforms.” (So much so that we’ve recently welcomed 20-year Food and Drug Law veteran and FDA expert Mark Mansour, Esq., to the Firm in part to address the influx of SaMD client needs. And if you’re wondering if your solution qualifies as SaMD, Kaitlyn advises starting here.)
Bethany Corbin weighs in on continued growth for femtech, which nearly doubled their venture capital dollars from 2020 to 2021. Bethany predicts femtech startups will expand beyond reproductive health, with menopause as a key health issues on their radar. She also sees femtech companies beginning to expand further into managing chronic care conditions for women, an opinion shared by Carrie.
Bethany notes a particular trend in social media advertising, as well: “There has also been a significant push by femtech companies to stop platforms like Facebook, Twitter, and other social media sites from blocking their content as inappropriate and explicit. In 2022, I anticipate that femtech companies will continue to challenge the marketing and advertising policies of mainstream social media platforms, which will also help reduce stigma surrounding women's health issues.”
But Bethany doesn’t stop at her love of femtech, as she’s also one of NGL’s Privacy and Security Experts. (If you’re lucky enough to go to sunny Portugal in March, you’ll hear her combine her interests to speak on the Ethical and Privacy Limitations of Femtech at the World Conference on Bioethics, Medical Ethics & Health Law.)
Bethany adds, “I am most excited to see the evolution of privacy and security frameworks as they adapt to evolving threats that result from new virtual-first and health-at-home care models. ...adoption of these more fluid care delivery models will require healthcare organizations to identify the unique privacy and data security risks that are present in at-home and fully remote locations.”
“I anticipate increased investment in privacy and security by these healthcare organizations, particularly those organizations that develop or use the Internet of Things and wearables. I believe larger healthcare organizations will be prioritizing security and cybersecurity measures for 2022 in a more deliberate and purposeful manner. Further, I am excited to see if the Department of Health and Human Services finalizes a new rule on healthcare privacy, given its preliminary rulemaking efforts to strengthen and adapt HIPAA to the changing healthcare environment.
“Finally, I am interested to see how the FTC will finally enforce its health breach notification rule against healthcare companies and whether such enforcement will have a meaningful effect on enhancing data privacy and security.”
Kaitlyn O’Connor, Esq., serves as the lead of NGL’s busy RPM Practice. No straying from the focus for our CPT Code Whisperer: Kaitlyn’s keeping her eye toward implementation and expansion of remote therapeutic monitoring. She also predicts some exciting mergers & acquisitions in the remote monitoring space with more digital health IPOs—and the emergence of more digital health unicorns.
Kaitlyn also predicts an improved focus on equity in digital health.
Partner Rebecca Gwilt believes that moving healthcare into patient homes, through hospital at home programs, in-home procedure innovations (like tele-phlebotomy and tele-radiology), and mobile primary and urgent care, is the next logical evolution of consumer-centric healthcare.
Keep an eye out for an upcoming podcast and blog series from counsel Casey Papp, who helped implement a Hospital at Home program in one of the country’s preeminent academic health care systems. She adds that “virtual front door” models will start to emerge from major health system players like hospitals and health insurers, so stay tuned for how these larger and more bureaucratic institutions duke it out with the feisty and fast moving telehealth and virtual platform providers.
The animal lovers of Nixon Gwilt (spoiler: it’s all of us) are also excited to see the growth of the tele-veterinary industry. Helping our tele-vet clients supercharge access to healthcare and wellness products and services for our furry families is feeding our brains AND hearts.
#2: What do you wish more healthcare innovators knew about their opportunities in 2022?
Reema gets straight to the point for those dragging their feet on telepharmacy: “Telepharmacy is the future of pharmacy and pharmacies should not miss out on adding these services to their traditional pharmacy business model.”
Katherine recommends that digital health companies examine the data they collect to identify the possibility of additional revenue streams: “There are opportunities in not only directly providing certain forms of the health care data that many clients collect as a matter of course in their business to these end users, but also in aggregating it and anonymizing the data to license to data analytics providers at a fee.” Bethany would, of course, add that when you’re working on a data capitalization plan, don’t forget about patient privacy!
Katherine also adds some key advice for startups: “Having a solid foundation of compliant corporate formation and governance documents, a compliant corporate structure (looking at you, telemedicine companies!) , and guidance on future fundraising goals are foundational, saving money and grief down the line.” Find out how to maximize the value of your startup before fundraising in Katherine’s value-packed webinar replay.
Bethany doubles down on Katherine’s advice. “Like most digital health startups, femtech companies often don't realize—until later stages in their development—the value of having a legal team assist with pitches, securing venture capital funding, and devising legally compliant corporate structures. Current femtech startups have told me that they wished they had known the value of having solid corporate documents prior to launch, and wished they had employed a legal team who could advise of unusual investment terms being presented by venture capitalists. Femtech startups have also advised that they wished they knew how long it can take to get through the legal due diligence process, especially when they don't have appropriate legal structures, policies, and procedures in place at the outset. I would encourage femtech clients to stop looking at legal documents and structures through a risk mitigation lens and, instead, consider how these documents and structures can actually help them secure industry partnership and funding faster.” Find out how your privacy structure can impact your funding options in Bethany Corbin and Ashleigh Giovannini’s recent webinar on the Top 3 Privacy Concerns for Digital Health Startups.
Kaitlyn wishes more people knew about “how remote monitoring can help measure and improve value in value-based healthcare.” It’s not just an additional set of billing codes that can generate fee-for-service revenue—monitoring patients and intervening when needed to improve care and outcomes can also positively impact your reimbursement levels in a value-based reimbursement model.
Bethany adds that “I would remind clients to actively stay abreast of changes to healthcare privacy and security laws. States are regularly proposing data privacy legislation to help fill the gaps left by HIPAA. A comprehensive understanding of these privacy laws, their status, the requirements they impose, and the impact on the client's business model is crucial. Further, I would encourage digital health startups to think of privacy not as a dreaded legal and regulatory requirement, but instead as an opportunity to build a foundational privacy and security baseline that can help clients close industry partnerships faster and secure funding quicker. Privacy and security are often only afterthoughts for clients and are not prioritized as part of the app or product development lifecycle. Reconceptualizing how we think about privacy, and understanding the role of privacy outside of risk mitigation, can be extremely beneficial for promotion of a client's business goals. I would stress to clients that privacy laws are not barriers to overcome, but rather represent an opportunity to enhance business structures and differentiate your brand.” If you want to keep up with changing state telehealth laws, be sure you’re following Nixon Gwilt Law on LinkedIn, as we’ll start publishing a monthly newsletter in January specifically to monitor these.
Carrie rounds out this round of advice by saying, “Femtech and Women's Health are more than just a passing trend!” She also says, “Patients and providers alike are becoming more familiar with the concept that care management does not end in between doctor visits. We should see increased utilization of RPM/RTM and other care management programs.” She also emphasizes that “opportunities for SaMD to enhance patient care will continue to evolve, and the time to begin thinking about an FDA pathway for your software is now.” You may not be able to tell by the typeface, but she had *that* tone of voice when she said that last word. Don’t wait!
Rebecca encourages healthcare innovators to accelerate their thinking about value-based payment models. Payers have never been more interested in incentive alignment, and they’re willing to work with provider networks and digital solutions companies to supplement their VBP strategy. If you’re not thinking beyond fee-for-service, you’re already behind!
#3: What emerging or changing risks are you keeping close watch on?
Reema is paying attention to state regulation and adoption for telepharmacy, as well as DEA regulation, which she broke down for you here.
Katherine is focused on the risk she continually monitors: “The ever changing and more stringent data privacy laws on a state by state level, as well as federally, require careful analysis of how this data is shared and for what purpose it is being utilized.” If you serve clients in multiple jurisdictions, you’ll want to (at the very least!) follow us on LinkedIn so you can sign up for our state telehealth changes newsletter when it starts next month. (Yes, we’re repeating that link because it’s important for you to keep up with these changes!)
Katherine also warns, “with the high volume of competitors in the space, competition for the best money will come down to details, including healthcare compliance in the corporate space. In addition to competition in this space, regulators are taking a closer look at corporate structure and how the burgeoning digital health and health tech market participants are set up.“
Kaitlyn echoes the concerns of Reema and Katherine when it comes to Digital Health clients. She’s on the lookout for audits of RPM providers and vendors. She’s also focused on device security for her clients.
Carrie thinks when it comes to the new RTM option, there is still a lot of confusion due to the current CPT code structure. (Click here for our breakdown on RTM codes, including a helpful FAQ.) She also worries for software platforms that are serving the function of SaMD without having gone through the appropriate FDA pathway.
Bethany says that she’s “continuing to monitor the venture capital space for femtech startups with the hopes of seeing increased investment in women's health.” Carrie echoes her thoughts by acknowledging that securing funding for femtech/women’s health is still a challenge. Bethany is also “monitoring trends in changes to advertising rules and platforms, and examining ethical considerations for new digital health technology.”
Bethany adds, “For 2022, I'm keeping a close eye on emerging state privacy legislation, regulation around algorithmic bias, and changes in the use and regulation of genetic data.”
Rebecca is monitoring how state insurance agencies are evaluating membership-model telehealth solutions–will they increase their scrutiny? Will they crack down on marketing language that they view as confusing to consumers? She is also keeping a close eye on state medical boards’ evaluation of the MSO-PC model that most telehealth companies are built on–will more states, like New York and California, start to institute policies that could threaten that business model? And last, with the Public Health Emergency likely set to expire in 2022, companies whose revenue is dependent on their ability to tele-prescribe medications in a fully virtual environment will need to figure out their pivot if stakeholders are unable to sway Congress and/or the DEA.
#4: What do you think will be the biggest surprise of 2022?
Reema says “other agencies might issue guidance on telepharmacy at the federal level, or request more information on this topic from industry stakeholders.”
Katherine says we’ll all be surprised by “the amount of spending/budget that will be allocated to obtaining the right kinds of data to further the goals of hospital systems, life sciences companies and payer groups.”
Carrie is looking at mandatory participation in new Alternative Payment Models.
Bethany thinks “it will be interesting to see how femtech as an industry evolves in terms of its focus for 2022. To date, most femtech has revolved around fertility and menstruation. However, there is significant untapped potential in women's health for chronic care, cancer, menopause, skin health, etc. It is important that we continue to expand the scope of femtech to include these much broader health concerns; otherwise, we risk conflating women's health with reproduction and limiting the scope of women's options.” Carrie and Rebecca add “Hell yes!” and lots of clapping hands and a mic drop emojis.
Bethany also says, “I think we're going to see enhanced enforcement of privacy and security requirements in 2022, given the transition to virtual and at-home care models. Digital health companies have routinely been operating in legal gray areas from a privacy perspective, and I think it will be surprising to those companies to see enhanced enforcement and regulations in these areas crystalize.”
This may be wishful thinking, but Rebecca hopes we are all surprised by bipartisan cooperation in Congress leading to the passage of Cures Act 2.0!
#5: Anything else you'd like to share about 2022 predictions and trends?
Carrie summed it up for everyone when she said: “I hope to see increased engagement by CMS and FDA with stakeholders under this Administration, helping policymakers to understand how innovative technologies are evolving and are successfully used "on the ground" by practitioners.”
Says Rebecca, “since the inception of this firm, we’ve learned that following and translating trends in policy, law, and business for our clients is what gives them an edge. We will spend 2022 following government regulations and policy and sharing our learnings and insights with you, so that you can get ahead of the curve for 2023 (yes, we’re thinking that far ahead, too)!”
Are you ready for 2022?
Whether you are in research mode, putting it all together in a plan, gaining consensus with your team, or ready to take action, we stand ready to help. With experienced healthcare innovation counsel across the spectrum of the industry, you’ll benefit from our collaborative approach and value-based fee options.
Click here to start the conversation.
And happy new year!
You don’t have to wait for our annual predictions to gain valuable business insights in healthcare innovation. We break down the hot topics every month!
