Latest News

ChatGPT-Image-Nov-26-2025-04_14_29-PM.png
DTC NewsGuest Columnist

Read this Before You Automate Patient Content

December 1, 2025 0

“When you talk to a doctor or a lawyer, there's medical privileges, legal privileges. There's no current concept of that when you talk to an AI, but maybe there should be.”

—Sam Altman, The Atlantic (2024)

Take it from the CEO of OpenAI: Confidentiality and privacy protections are among the biggest unresolved issues for those interested in using emerging artificial intelligence tools in settings such as law and healthcare. Strict professional privileges exist for a reason. We ask people to share the most sensitive moments of their lives so we can educate, support, and guide them. They open up because they believe their words will be handled with care, kept in context, and never used against them.

AI promises speed and scale, but it does not confer privilege. The tension shows up in daily work. A team wants to turn a powerful interview into a plain-language explainer. Another wants multilingual versions of an adherence story. A third needs a short script for a Patient Ambassador™ video. AI could help each project move faster.

Yet the raw ingredients (transcripts, recordings, voice messages, emails) can contain names, dates, locations, adverse events, trade secrets, and distinctive phrases. Feed those into a general model and you may create a trail you can't fully see or control. Even when policies say inputs aren't used for training, exceptions exist. Retention rules evolve. Humans sometimes review snippets. The words you were trusted to protect may travel further than you intended.

Evolved Privacy Policies

Across the world, legislators have passed regulations to protect their constituents from overly intrusive data harvesting practices. The life science industry and their agencies have established processes to comply with regulatory mandates, in many cases being more restrictive than required. For example, the European Union's GDPR rules have emerged as the industry’s best practice, even outside of the EU's jurisdiction. The point is to be as restrictive with data, and as respectful with patients’ safety and privacy, as possible.

Such good faith efforts are important when building a trust-based partnership among equals. And they're expected. Privacy, for patients, isn't abstract. It's protection from harm that could affect an already vulnerable population. Patients and caregivers are motivated to work with the life science industry for many reasons: human connection, empowerment, motivation, education, inspiration. Becoming a dataset or having sensitive information exposed isn't one of them. So, to enter the AI era respecting privacy, three rules apply.

Rule #1: Guide the Process

The lead in patient engagement needs to be held by a sentient human being like yourself. A human can be held accountable. A human also knows that they could, now or in the future, be a patient themselves. So, they understand the gravity of their responsibility and know how to address concerns and apprehensions.

This only works if that human is more than just an order taker. They have to be familiar with the patient, competent at their craft, and able to guide through a regulatory-compliant cocreation process.

Rule #2: Have a Conversation About Consent

If a patient contributes to creative content, they should know exactly how that piece will be created, where AI may help, and where humans will review.

They should understand the process for creation, publication, and future reuse. If they change their mind, the path to withdraw should be simple and honored quickly. A checkbox at the bottom of a long policy is paperwork. A clear discussion about purpose, limits, and control is respect.

Rule #3: Maximize Meaning, Not Data

Once the ground rules for cocreation are understood and the humans have sorted out how they will work together, AI assistance can come into play. Generative AI can be a detriment to authenticity and has a measurable image problem within the patient and caregiver community[i]. So if you introduce AI, do so only on a need-to-know basis and preferably only on behind-the-scenes processes.

For example, for an LLM to assist with drafting, it won't need the full, raw record of life. It will need meaning. That means removing identifiers and letting AI operate on a focused, safe excerpt or summary of the original notes. Always ask: “Is this information necessary to accomplish what we're looking for?” If the answer is yes, and if the information is privileged, manual work or a secure, on-site system is required.

Keep the Human Voice at the Center

The reason we always emphasize authenticity is because real human stories change behavior more than engineered, sterile content ever will. AI can help translate and organize those stories. It cannot live them.

We can safely expect AI to become better at mimicking human nuances: imperfect phrases, deliberate pauses, heart-wrenching rawness, elevating inspiration. But as generative content floods every channel, audiences will reward not only what feels true but what they know to be real and accountable. Whatever you do, never pass artificial patients off as real ones. Break that promise once, and all your work could be called into question.

Respecting these guardrails prevents rework. When teams avoid over-collection on the front end, they spend less time redacting. When consent is explicit, legal reviews move faster. When provenance is built in, Medical-Legal-Regulatory discussions focus on substance, not process.

The result is a speedy and satisfying mode of engagement with predictable cycles, fewer surprises, and assets that stand up months later when someone asks, “Where did this come from?” If you wouldn't want to read a prompt and its source materials in a public forum, don't put them in a model you don't control.

Environment and Expertise

Teams that want to use AI will need the right environment and the right expertise. The environment should match the stakes: private instances when identifiable data is unavoidable, zero-retention settings, strong access controls, short retention windows, encryption in transit and in storage, and separation between systems that store identifiers and systems that generate content.

The expertise is the human part: interviewing that captures meaning without excess detail, editorial judgment that keeps education separate from advice, cultural fluency in every language we publish, and regulatory rigor that anticipates hard questions before they're asked.

This is not easy to build, but the right agency can help select the right use cases for AI, set up the protected environment, convert legal principles into usable workflows, and defend the final product. After all, they know exactly how it was made.

AI can have a place in responsible patient engagement. Privacy has the first place. Until society gives AI conversations the protections we expect from medicine and law, act as if every patient word entrusted to you is a promise. Keep that promise, and you'll earn the speed AI offers without spending trust you cannot afford to lose.

[i] Data from a recent survey SNOW conducted with 297 patients and caregivers suggests there is a strong negative feeling toward generative AI in patient content: 42% are not open to AI being used at all in the creation of content involving patients or caregivers.

Oliver Portmann

7f6acaaf-6452-4826-ae86-00d9cf72e91b.jpg
DTC NewsGuest ColumnistSponsored Content

The End of DTC? Time to Rethink Patient Engagement

November 11, 2025 0

If the FDA’s targeting of TV ads and social media influencers makes one thing clear, it’s that the biopharma industry is under the microscope. Promotions once considered “safe” are now fair game for untitled letters, warning letters and cease-and-desists. Understanding this new environment matters, but it is not the real story. The real story is what comes next. Direct-to-patient communication won’t disappear but will have to evolve. The future isn’t bigger media buys. It’s stronger relationships built on clarity, respect, and measurable help for real people.

That’s why many leading biopharma brands are rethinking their patient engagement strategies—not by walking away from it, but by grounding it in authenticity. For those clients, SNOW creates engagement that connects patients with information they can trust, stories they can relate to, and support they can act on.

From Mass Marketing to Meaningful Connection

The next chapter of DTC rewards brands that trade frequency for trust, interruption for invitation, and claims for context. Patients want to understand whether a treatment is right for them, what risks there really are, and how to talk with their clinicians. If your content does not answer those questions, it won’t earn attention, and it certainly won’t earn trust.

The enforcement wave simply accelerates a truth we’ve always championed: fair balance is not a checkbox; it’s a content strategy. When patients grasp the real benefits and risks of a treatment, they are far more likely to have informed, productive conversations with their HCPs. That’s what genuine patient engagement looks like and what the regulatory shift now demands.

What’s been Flagged

In the current regulatory enforcement wave, a pattern is emerging:

Risk Omission or Minimization: A persistent issue is that major safety risks (boxed warnings, serious adverse events) are not adequately presented or are omitted altogether.

Misleading by implication: Ads are using phrases, visuals, or results that suggest more than data supports (for example, emotional/social quality of life improvements.

Visual and format distractions: Use of distracting visuals, scene changes, font/contrast/or placement (especially in “major statement” risk disclosure) so that risk messaging is less noticeable or readable.

Mechanism of action overclaiming: Making efficacy claims or implying understanding of how the drug works when clinical pharmacology doesn’t support full understanding.

Promotional medium: ads, TV, online video, sponsored links: Many letters reference DTC broadcast or video advertising, and increasingly sponsored‑search links or equivalents.

What to Build Instead

1) Human support changes outcomes.
DTC cannot do what a trained Health Educator, nurse navigator, or peer ambassador can do. Build programs that let patients ask questions, explore scenarios, and map decisions to their personal context, and offer empathy backed by rigor. SNOW helps clients operationalize that human layer, training every touchpoint on on-label boundaries, adverse-event capture, and cultural competence.

2) Trust is the currency.
Trust forms when information is credible, complete, and authentic. That means making risk information first-class content, not a fast scroll. It means showing your work and helping patients understand what the data really says and why it matters.

3) Clear beats clever.
The future favors clear, instructive communication. Define who a therapy is and is not for. Translate clinical endpoints into outcomes a patient can understand. Use graphics that slow the eye and aid comprehension.

4) Impact over impressions.
Stop chasing clicks and eyeballs. Optimize for high-value patient actions: diagnosis, guideline-concordant starts, and persistence at clinically meaningful milestones. If a channel cannot advance those goals while maintaining fair balance, it does not belong in the plan.

5) Governance as a growth engine.
Strong promo-review SOPs, creator rules, and documentation are not red tape. They are brand safety and speed. When enforcement ramps up, teams that can prove discipline in real time keep moving while others scramble.

6) AI operates under its own set of rules.
Generative AI has entered healthcare, but it’s not engineered for fair balance. SNOW uses AI to improve process efficiency, not to replace human storytelling. Real patient voices remain the foundation of authentic communication.

The New DTC: Built for Trust

The next era of patient engagement is one where education replaces promotion.

  • Owned education hubs, such as brand websites, should feel like care, not ads. They should feature real patient experiences, plain-language, and decision aids that patients can print and take to appointments.
  • Editorial storytelling should mirror the questions patients actually ask: “Is this for me?” “What should I watch for?” “How will this fit into my life?”
  • Health Educator and peer-ambassador programs should extend that learning journey, guiding patients with empathy and regulatory compliance.

These are the programs that move the needle on understanding, adherence, and trust.

The bottom line

DTC doesn’t end here. Bad DTC does. Now is the time to replace noise with nuance, and messaging with meaning. Build for trust and clarity, and your engagement won’t just survive the crackdown. It will help people make informed decisions with their clinicians, and feel confident about the path they choose.

Lynn Kirkpatrick

DTC-National-Blog-Imageresize-1200x675.png
Guest ColumnistSponsored Content

Measurable Outcomes: The Impact of Coordinated HCP and DTC Campaigns

August 14, 2025 0

Patients and providers often engage with health content during overlapping time frames. When HCPs and consumers are aligned, behaviors change and brands grow. While many marketers see HCP and DTC alignment as ideal but difficult to execute, the landscape is shifting.

With the trend toward health consumerization, today’s patients are more informed, empowered, and proactive. Today, 60% of Americans get more medical info online than from doctors (Merck), but many feel overwhelmed and confused by the sheer volume of evolving health content. Consumers now cross-check sources, prioritize “what works for someone like me” relevance, and come to appointments already informed, often driving the treatment conversation.

Still, providers and hospital systems remain the most trusted information sources (McKinsey, 2024), meaning digital-first discovery still needs validation from credible medical authorities.

When consumers ask for a brand and HCPs are already aligned on its clinical value, prescriptions increase. Programmatic strategies like PulsePoint’s that coordinate touchpoints across both audiences can deliver the scale, trust, and impact needed to drive action.

How to Align HCP and DTC Healthcare Marketing

Patients and providers move fluidly through the healthcare journey. Patients come and go based on symptoms, diagnoses, and life events, and providers based on new data, evolving guidelines, and clinical experience. 

To influence behavior on both sides, healthcare brands must move beyond siloed efforts and adopt a unified, real-time approach to HCP and DTC marketing. That starts with investing in health-specific programmatic technology that enables precision, agility, and scale. By activating campaigns based on real-time condition signals, content behavior, or HCP clinical activity—and dynamically adjusting spend, targeting, and creative—brands can keep both audiences in sync as they move through their decision-making journeys. 

Executing this effectively requires four foundational capabilities:

  • Precision Targeting – Reach the right audiences. Use real-time health signals and behavioral insights to reach the most clinically relevant, engaged consumers and the HCPs most likely to treat them.
  • Omnichannel Execution – Deliver responsive messaging. Execute a smart media mix HCPs and consumers actually use, including display, CTV, OLV, native, and more, to ensure engagement regardless of where the audience is spending time. A smart media mix ensures you’re maximizing reach through non-endemic and endemic environments. 
  • Measured Media Effectiveness – Measure what matters. Metrics like NRx lift, ROAS, HCP engagement, and deduplicated audience performance provide a full view of health journey impact.
  • Adaptive Optimizations – Use dynamic insights to drive data-driven adjustments to campaigns in real time, including fine-tuning messages, targeting, channel investments, and creatives to maximize performance.

When executed well, this HCP-to-DTC crosswalk improves marketing efficiency and directly influences patient outcomes and brand growth.

A Real-World Example of Impact

Butler/Till, a leading marketing agency, activated an HCP/DTC omnichannel campaign powered by PulsePoint’s health-first programmatic platform to elevate a gastroenterology brand facing low consumer awareness despite clear clinical advantages.

On the HCP side, the campaign focused on precision targeting and positive prescribing outcomes. Using PulsePoint’s DirectMatch™ technology, the team validated and reached individual HCPs with relevant prescribing activity. To expand beyond the existing target list, Clinical SmartLists™ were used to identify additional providers actively treating the condition or engaging with related brand content. Sequential messaging played a key role in nurturing HCP engagement, retargeting brand site visitors, and tailoring outreach based on behavioral signals to move them closer to prescribing action.

On the DTC side, the campaign centered on contextual relevance and intent-based targeting to drive consumer engagement. PulsePoint’s Health Pages and Health Populations (Plus) were used to identify high-intent users actively consuming condition-related content across the web. To further improve precision, the team built Bespoke Audiences™ using deidentified claims data, targeting audiences with a higher likelihood of condition prevalence. Campaign scale was expanded through integrations with leading third-party audience providers. Brand site visitors were also retargeted to reinforce awareness and deepen consideration along the path to action.

The result? Coordinated exposure met consumers in discovery mode and ensured HCPs were primed to prescribe, creating a powerful crosswalk and connected care journey that drove measurable impact through aligned engagement.

According to a leading independent pharma measurement firm, this integrated campaign delivered the largest NRx lift to date for the brand. It’s being touted as the most successful campaign in the brand’s history. In just six months (January–June 2024), the campaign showed significant scale and brand impact, delivering a positive ROAS of 4.32 across consumer audiences and 6.48 across provider audiences.

Curious what success looks like? Download the full case study here. 

Why the HCP-to-DTC Crosswalk Matters More Than Ever

Healthcare journeys don’t unfold in silos. Patients research, providers prescribe, and, increasingly, their decisions influence one another. That’s why an aligned HCP-to-DTC strategy is no longer a nice-to-have; it’s essential.

When brands guide both sides of the prescription conversation, they build clinical confidence and consumer demand in tandem. With the right data, creative, and channels activated, marketers can deliver synchronized experiences that move audiences toward action. As the success of PulsePoint and Butler/Till’s campaign demonstrates, the most impactful healthcare strategies aren’t linear—they’re crosswalks. And when executed well, they lead to something far more powerful than engagement: measurable outcomes.

Amy Fieber

AdobeStock_1574801002-1200x800.jpeg
Guest Columnist

DTC Marketing in 2025: It’s Time to Rethink the Conversation

July 28, 2025 0

I recently returned from the DTC National conference, and one theme was clear across nearly every session: hotel carpet has endless charm. But also … the traditional direct-to-consumer marketing playbook is overdue for a revamp. In an industry that still leans heavily on the familiar “ask your doctor” message, it’s becoming increasingly clear that our patients — and their expectations — have moved on and evolved. And marketers are being charged with figuring out how to keep up.

The old model of pushing a product message and hoping it sticks isn’t enough anymore. Patient communication boundaries are begging to be pushed, and those who are up to the challenge are standing out in the space. Today’s health-minded consumers expect more. Period. They expect (read: require) brands to meet them where they are, to understand their needs before they articulate them, and to offer information and experiences that make them feel smarter, more confident and more in control of their health journey. Give them what they need and want before they even know they need and want it.

From Product to Platform: Building Brand Ecosystems

One topic that resonated with me (and sits on my mind daily because the pursuit is ongoing and ever-changing!) is the need to reframe brands for engagement versus as standalone products. The old CPG model stood for creating loyalty, identity and community. That still stands, but we also need to go further and help patients navigate a world full of data points, big decisions and an often overwhelming and fragmented health care system. We need to show up as their trustworthy friend.

… Enter AI! We’re learning and building responsive strategies as we go. We’re constantly looking for ways to incorporate meaningful personalization — meeting them in their moments. Whether it’s simplifying complicated treatment options, providing credible lifestyle tips, sharing patient testimonials or delivering emotional support through a diagnosis, our content needs to work harder, smarter and more responsively. Patients don’t want a transactional relationship with their treatment — they want a partnership that integrates into their life, anticipates their needs and evolves with them.

I love a good shortened word or acronym, so when someone referred to DTC as “dedicated to connect” instead of “direct to consumer,” I immediately logged it to memory and couldn’t wait to use it. So here I am using it! [Hold for applause.]

The Road Ahead

The conference painted a clear takeaway: The stakes are higher, the opportunities are greater and the brands that will win are the ones willing to lead the way into a more connected, patient-centric future, giving them reasons to talk to and trust us.

Katie Trueman

AI-Compliance-1200x800.png
DTC in FocusGuest Columnist

Transforming Data Compliance into a Competitive Edge: The Role of AI in Aligning DTC Marketing and Regulatory Goals

May 16, 2025 0

In the rapidly evolving landscape of direct-to-consumer (DTC) pharmaceutical marketing, data compliance has traditionally been viewed only as a necessity— which is often perceived as a constraint on marketing-driven growth, personalization, and operational agility.

The advent of artificial intelligence (AI) is revolutionizing this perspective, positioning data compliance as a strategic asset that enhances marketing effectiveness, improves data integrity, and reduces risk. Today’s AI technology not only automates and streamlines first-party data collection and handling but also facilitates collaboration, customized reporting, and stakeholder-specific recommendations.

The Evolving Landscape of DTC Pharmaceutical Digital Marketing and Media

In early 2023, the pharmaceutical industry surpassed the technology sector to become the second-largest industry in advertising spending, increasing its share to 14% of total ad expenditures, second only to the retail industry. This significant investment underscores the industry’s commitment to direct consumer engagement as the engine for marketing-driven growth. However, it also amplifies the challenges associated with ensuring that marketing strategies comply with stringent regulatory standards.

A recent study of the data compliance risks on pharmaceutical websites by the Association of National Advertisers (ANA) and Compliant[1] found that many healthcare and pharma websites failed to meet minimum standards for consumer data collection, consent, and data sharing. Companies like Better Help[2], Costco[3], and many others have found themselves in regulatory and legal crosshairs. Even industry associations have been targeted and found guilty by regulators[4], leaving marketers with no choice but to look for ways to own data compliance themselves.  This has led to a need for new tools to increase efficiency and accuracy in this critical area.

Without ethical guidelines and proper controls, large-scale consumer data collection, processing, and activation expose brands to significant liability and risk—often with minimal transparency or governance.

The rise of AI has expanded data compliance capabilities across multiple applications in the digital marketing business, including the ability to now build, create, analyze, enhance, and interact with consumer data in real-time in a “safe” and consistent manner. Done well, AI can empower marketing, technology, and compliance teams to operate together with greater precision and impact. AI’s ability to integrate compliance workflows with data optimization across websites, media campaigns, and cross-media applications adds unprecedented value for the DTC marketing process.

AI-Driven Data Compliance: A Strategic Asset

Traditional consumer data compliance processes in pharmaceutical marketing are often manual and time-consuming, leading to delays and inefficiencies. And while more than 70% of brands rely on agencies and partners to be educated and act in a legal and ethical fashion, less than one in four used automation to audit and verify data compliance across their digital marketing supply chain[5].

AI helps address these challenges by enabling detailed data compliance testing, verification and remediation across various digital platforms, including websites, applications, and media campaigns. AI-driven tools ensure real-time adherence to regulatory requirements, enabling marketing teams to execute privacy-first media campaigns swiftly and confidently.

Jamie Barnard, CEO of COMPLIANT, emphasizes, “Leveraging AI-driven data compliance is both a sword and a shield. Done right, it can transform this complex subject from a regulatory and business barrier into a competitive advantage. It allows DTC marketers to innovate confidently, technology teams to reduce time allocated and compliance teams to sleep well at night. And it saves money from fines and resources, making the CIO and CFO happy”

Enhancing Data Integrity and Media Quality

In DTC pharmaceutical paid media, the collection and utilization of first-party data are crucial for effective consumer engagement. Finding and marketing to consumers in the healthcare space presents some unique regulatory and legal challenges – not the least of which is privacy and data integrity.

AI-powered compliance platforms continuously audit data collection points, consumer interactions, consent frameworks and other quality metrics to ensure media campaigns are accurate, relevant, and compliant with privacy regulations. This helps both the customer and the company by leading to:

  • Improved Targeting: Ensuring that marketing efforts reach the appropriate audience segments.
  • Enhanced Personalization: Delivering tailored content that resonates with individual consumer needs.
  • Increased Consumer Trust: Demonstrating a commitment to data privacy and security.

Pete Dannenfelser, a pioneer in digital healthcare marketing communications, notes, “The unexpected value add of the integration of AI in compliance processes is that it not only mitigates risk, but also elevates the quality of our data, enabling more precise and impactful marketing efforts. This not only leads to better marketing, but delivers higher quality, more appropriate messaging for the customer.”

Fostering Continuous Collaboration Between Teams

AI facilitates seamless collaboration between compliance and marketing teams by providing unprecedented transparency and control, real-time insights, and automated reporting. This continuous alignment reduces the need for multiple meetings and streamlines communication, allowing teams to focus on strategic initiatives and objectives.

Shailee Vimadalal, a partner at ZS Associates, observes, “Implementing robust AI-driven compliance solutions fosters greater transparency and control, enabling marketing and compliance teams to work in harmony towards shared objectives.”

Real-World Application of AI-Driven Data Compliance in Digital Marketing and Media

Today, data compliance platforms are removing risk and enhancing marketing performance for leading consumer brands worldwide.

Consider a pharmaceutical company launching a new DTC campaign. With an AI-driven compliance platform, the company can:

  1. Confidently Activate Consented First Party Data : AI ensures that first-party data collection methods comply with privacy laws, maintaining data integrity.
  2. Ensure Compliant Media Buying: AI ensures the impressions, audiences and media purchased through agencies/DSPs and from digital media vendors (publishers, SSPs and other 3rd party data sources) are properly consented and have higher data integrity.
  3. Facilitate Cross-Functional Collaboration: Real-time compliance transparency, controls and insights promote a unified approach to campaign development which delivers greater trust and confidence to the organization.

This integration not only expedites campaign launches, but also helps ensure that all regulatory requirements are met, thereby enhancing the campaign’s overall integrity and effectiveness.

The Return on AI-driven Compliance

By embedding AI into compliance processes, pharmaceutical companies can transform a traditionally manual, reactive function into a proactive strategy that drives business value. The benefits include:

  • Operational Efficiency: Streamlining compliance tasks reduces time-to-market for new campaigns.
  • Risk Mitigation: Proactively identifying and addressing compliance issues minimizes the likelihood of regulatory penalties, lawsuits or reputational damages.
  • Enhanced Outcomes: Marketing-driven growth is predicated on finding the right customer, and serving them creative ads in context and with consent. Using data integrity and compliance metrics becomes an additional KPI.

Actionable Steps for DTC Marketers

To leverage AI-driven data compliance in digital media effectively, DTC marketers should:

  1. Assess Current Data Compliance Processes: Identify areas where AI can automate and enhance existing workflows.
  2. Invest in AI-Powered Compliance Tools: Select platforms that offer real-time monitoring and analysis of marketing activities.
  3. Promote Cross-Functional Collaboration: Encourage ongoing communication between marketing and compliance teams to align objectives.
  4. Stay Informed on Regulatory Changes: Utilize AI tools and services to monitor and adapt to evolving regulations, ensuring continuous compliance.

By adopting these strategies, pharmaceutical companies can turn compliance into a catalyst for innovation and a significant competitive advantage in the DTC marketing landscape.

Conclusion

The integration of AI into digital media data compliance marks a pivotal shift in DTC pharmaceutical marketing.

By automating compliance tasks, creating transparency among teams, enhancing data integrity standards, and fostering collaboration between marketing, IT and compliance teams, AI can transform compliance from a regulatory obligation into a strategic growth opportunity.

Pharmaceutical companies that embrace AI-driven compliance solutions are better positioned to navigate the complex regulatory environment, drive innovation, and achieve sustained success in the competitive DTC market.

 

Sources:

[1] 2024 ANA Compliant Website Benchmark Report (LINK)

[2] FTC Better Help announcement (LINK)

[3] Costco sued for Facebook pixel placement on Pharmacy homepage (LINK)

[4] IAB TCF framework judged illegal (LINK)

[5] ANA Compliant report

Ian Wolfman

Washington-DC-shutterstock_2307968267.jpg
DTC in FocusGuest Columnist

FOFO: Fear of Finding Out and the Impact of the Washington My Health My Data Act on Pharmaceutical Company Compliance

August 12, 2024 0

The recently passed Washington My Health My Data (MHMD) Act stands as a significant legislative milestone, reshaping data requirements for pharmaceutical companies and raises a new specter of non-compliance. Against a backdrop of increasing regulatory scrutiny and privacy concerns, understanding the implications of the MHMD Act is a critical first step and learning that they may not be in compliance is weighing on the minds of CEOs, CMOs and Chief Privacy Officers (CPOs) across the industry. Compliance Officers are asking what the impact of the MHMD Act will be, and, more importantly, how can they ensure that their companies are aligned with changing regulations?

 

What is the Legislation?

Enacted on March 31, 2024, the Washington My Health My Data Act represents a comprehensive framework aimed at enhancing health data ownership and privacy. Key provisions of the MHMD Act include obtaining explicit authorization from consumers before selling or sharing their health data, expanding the definition of health data to encompass various aspects of physical and mental health, increased transparency regarding data privacy practices, and stricter accountability measures in case of breaches or violations including enforcement actions by the Attorney General and private litigants.

 

Of course, the MHMD Act has profound implications for pharmaceutical companies, reshaping their approach to data privacy and compliance. In an industry characterized by stringent regulations and waning consumer trust, adherence to the MHMD Act is critical for several reasons, not the least of which being Regulatory Compliance. Healthcare companies operate within a complex regulatory landscape, subject to oversight from federal agencies such as the FDA, FTC and DEA. The MHMD Act introduces additional compliance requirements, necessitating proactive measures to ensure adherence and avoid negative PR and costly penalties.

 

Identifying the source of one’s FOFO: Fear of Finding Out

 

Pharmaceutical companies, their agencies, and internal compliance have always been a critically important part of program execution, but the stakes have just gone up. In fact, in this new compliance environment, one could now consider a proactive approach to data compliance management as a competitive advantage for the business. Specifically, the companies with the right approach and toolset to automate workflow, will have a new competitive advantage whenever engaging in marketing programs and at all digital consumer touchpoints. It also means the end of FOFO, because finding out about your level of compliance shouldn’t be a fearful situation.

 


Shailee Vimadalal, a partner at ZS Associates is a global management consulting and technology firm specializing in transforming healthcare and beyond said about these marketplace changes, “The Washington My Health My Data Act (MHMD) brings a renewed focus on consumer consent for data use by the US pharmaceutical industry. This necessitates investments in personal data collection and handling practices to ensure greater transparency, commitment, and control for the consumers on how their data and how it is being used. Implementing a robust consent and preference management solution can be a strategic step for pharma companies to navigate this evolving landscape.”

 

In the pharmaceutical industry, ignorance is never an acceptable reason for being out of compliance. In addition, once a company becomes aware of an issue, its leaders are obligated to act. 

 

This draws a direct line from the CEO to the office of Compliance and across to the head of IT as Data Management challenges begin to emerge. Pharmaceutical companies handle vast amounts of sensitive patient data, including clinical trial results, medical records, and adverse event reports. Laws like this touch even simple “request more information” type functionality on product websites and extend throughout all brand digital media. Compliance with the MHMD Act requires attention to robust data management systems to safeguard the privacy and security of this information.

 

This Washington act will also impact Marketing Practices. The MHMD Act's provisions for consumer authorization and data-based targeting have significant implications for pharmaceutical marketing strategies. Companies must ensure compliance with opt-in requirements and adopt data privacy-centric approaches to these campaigns while ensuring strict compliance with data-usage disclosures. In other words, proactive and skillful compliance in marketing workflows will become a key strategic and tactical competitive advantage for pharmaceutical brands in 2024.

 

Pete Dannenfelser, a pioneer of digital healthcare marketing communications, offers insights into the impact of the MHMD Act on pharmaceutical company compliance. “The industry's historical commitment to conservatism and caution may make change easier. But the consequences of non-compliance underscores the importance of leveraging tools to assess the current state of a company’s digital platforms and readiness for what’s next.” 

 

Dannnfelser goes on to say, “While these newly enacted requirements will hit the entire industry, pharmaceutical companies operating under Corporate Integrity Agreements (CIAs) must be able to act quickly to uphold stringent compliance standards. Non-compliance with the MHMD Act could jeopardize adherence to CIAs, leading to severe consequences.”

 

Amidst the challenges posed by the MHMD Act, Dannenfelser recommends leveraging new AI-powered digital tools to navigate compliance requirements effectively. In fact, adding these powerful new tools to workflow should foster a competitive advantage, not only in day-to-day tactical execution, but also with strategic planning in a rapidly evolving new regulatory environment.

 

“Advertisers can only effectively manage what they can measure, so optimal integration of compliance standards into workflows become an essential element of all digital media campaigns and web properties,” says Jamie Barnard, CEO of COMPLIANT, the industry leader in AI SaaS compliance software.

 

A.I. algorithms analyze vast amounts of data to assess compliance risk levels, identifying potential areas of non-compliance and guiding companies in prioritizing remediation efforts. These learnings can help pharmaceutical companies create comprehensive compliance roadmaps, outlining steps to ensure compliance with data privacy regulations, opt-in requirements, and data-based marketing practices. Beyond that, AI technologies enable real-time monitoring of compliance activities, allowing companies to detect and address compliance issues promptly and proactively, minimizing the risk of regulatory violations and associated penalties. As any seasoned Rx marketer can tell you, a little proactivity can go a long way when dealing with regulatory bodies. 

 

 

The Washington My Health My Data Act ushers in the next era of significant regulatory data requirements with far-reaching implications for the healthcare industry among others. So, what should pharmaceutical companies be doing now to manage FOFO and stay ahead of this and other emerging data laws?

 

  • Embrace A.I.-driven tools to reactively assess active current content and proactively review new digital assets.

 

  • Adopt proactive compliance strategies leveraging tools and revising policies to be flexible enough to change with new laws.

 

  • Respond quickly when issues are identified – oftentimes, the remediation is not as intimidating as it seems, especially if repeatable processes and guidance is enacted.

 

Ian Wolfman & Pete Dannenfelser

tiktok-ban-shutterstock_2336413347.jpg
DTC in FocusDTC NewsGuest Columnist

The TikTok Ban and What it Means for Pharma Marketers

August 1, 2024 0

What’s happening with TikTok?

As many of you have heard, TikTok has been formally banned in the U.S. (it will take effect by January 2025 at the earliest). The major reason for the ban is the national security threat from the Chinese government, which could potentially use it to spy on Americans or weaponize it to covertly influence the U.S. public by amplifying or suppressing certain content. While TikTok management is willing to fight the ban in court and looking for various workarounds, it is forecasted that the platform will most likely be purchased by one of the U.S. tech companies. Under the bill, TikTok will now have 270 days to divest. However, an additional provision could also see TikTok apply for an extra three months under certain conditions (e.g., if it’s negotiating with buyers and needs more time to finalize the deal).

We already see conversations around potential platform buyers. Experts say that Meta is the least likely candidate in this case, and it is more realistic to consider companies such as Oracle, Microsoft, Walmart, and Triller.

What does it mean for us as pharma marketers?

It is hard to predict how the platform will evolve if TikTok wins its legal case or if either of the players acquires it. This means it is too early for pharma marketers to consider future strategic considerations.

Regardless of the outcome, it’s obvious that the situation casts a shadow on the platform's reputation in the eyes of pharmaceutical marketing stakeholders who were considering it for potential social initiatives. It also may affect the U.S. social media landscape, where we can expect a spike in snackable video content on Instagram Reels or YouTube Shorts driven by migrated U.S. influencers.

We haven't had a chance to produce any content for the platform in the past due to regulatory implications on our clients' side. However, we are currently working on Instagram and Facebook Reel ads development for clients, which is a great opportunity to start exploring the format deeper as an alternative to TikTok.

When considering influencer marketing, it would be fair to eliminate TikTok as a platform for potential partnerships and focus on Instagram and YouTube. X (former Twitter) is a questionable platform for HCP influencers as it is still experiencing some market backlash and had a 7% drop in brand use in 2024.

The upcoming changes aren’t supposed to significantly affect the way we’ve been strategizing our clients’ social presence. However, we should keep exploring alternative platforms to help brands engage effectively with patient/HCP audiences while keeping a close eye on the next steps on the TikTok side. As an agency committed to staying ahead of the curve, we're prepared to navigate these changes alongside our clients and help them thrive in the evolving social media landscape.

Helen Hoye

hueristics-image-2-1200x819.jpg
DTC in FocusDTC NewsGuest Columnist

Using Heuristics and Powerful Creative to Connect HCPs to Your Brand

August 1, 2024 0

Healthcare providers are analytical and methodical professionals who make important decisions every day affecting the lives of their patients. Constant learning is critical to their performance.

But HCPs are also human, with egos, personal lives, daily pressures, and jobs that impose long hours and high demands. Their time and attention are at a high premium.

To effectively educate HCPs about a brand and differentiate it in their minds, marketers must optimize product messaging so that it quickly and vividly resonates with each audience segment. An effective tool for doing this is heuristics, a term that encompasses a process of psychological shortcuts that simplify and accelerate decision-making.

We all use heuristics in our everyday lives, especially when faced with new or high-volume information and a limited time to process it. In a stressful situation, for example, we might base our response on how we successfully handled a similar situation in the past.

In healthcare marketing, there are numerous heuristics domains that commonly affect the decision-making of HCPs. Some of these include:

Background Contrast Effect: People are more likely to select an option when an inferior choice is present, i.e., they judge an option based on its contrast with a lesser option rather on its merits.

Instant Return: People want a return on their investment (time, effort or money) immediately.

Novelty Bias: People often think newer is better.

Negativity Bias: People pay more attention to and give more weight to negative things than positive things.

Zero-Risk Bias: People prefer reducing a small risk to zero rather than making a larger reduction in a bigger risk.

 

Understanding and prioritizing which heuristics are applicable in a specific situation – i.e., which are most relevant to target HCPs and pertinent to the features of a particular brand – is an important step in developing effective brand messaging. Here are some examples of how heuristics can guide and optimize messaging.

If the dominant heuristic is Instant Return, optimized messages will focus on how quickly results can be expected, e.g., “Observable results in two weeks, with proven significance at six weeks,” or “Improvement you and your patient can both see in as little as six weeks.”

If Novelty Bias is the dominant heuristic, what’s new and unique about the product will be the focus, e.g., “Only Product X has once-daily dosing and no meal restrictions, which may help your patients remain compliant.”

Similarly, if the dominant heuristic is Background Contrast Effect, optimized messaging will emphasize the drawbacks of an inferior choice (such as remaining untreated for a particular condition) to underscore the value of a different option, e.g., “The impact of body movements isn’t just physical; even mild body movements hold patients back from making meaningful connections and performing daily tasks”.

Of course, optimized messaging isn’t the end of the story. The next step in successfully connecting HCPs to a brand is delivering those messages through powerful creative that communicates quickly and is pertinent, impactful, and memorable. Powerful creative is also visually compelling – studies show that the vast majority of human communication is nonverbal, people process visual information much faster than text, and they retain more of what they see than what they read or hear.

Ultimately, powerful and effective creative is distinguished by four key hallmarks. First, it’s quick, to the point, and communicates in the blink of an eye. Words and pictures work seamlessly together to deliver a disarmingly simple idea. Second, it’s relevant, telling a meaningful story that resonates with viewers and indelibly marks the brand message in their minds. Third, it makes an emotional impact, connecting with the hearts and minds of viewers and communicating benefits, not just product features. And fourth, it’s distinctive, standing out and delivering a message so fresh, daring and different that it’s impossible to overlook.

Optimized brand messaging that is guided by heuristics and realized by powerful creative is a solid foundation for effective advertising and a confirmed way of connecting HCP’s to your brand.

Jody Van Swearingen

AdobeStock_221024990-1200x800.jpeg
Guest ColumnistXpectives.Health in Focus

Artificial Intelligence and DTC Marketing: The Real Opportunities

March 22, 2024 0

The transformative power of artificial intelligence is just beginning to be realized in pharmaceutical marketing. While machine learning and AI have been around for years, it’s only recently that we’ve found ourselves in what I often describe as a technological Wild West. (Interesting sidenote affirming my choice of words: AI summarizes Wild West as “a complex and multifaceted period blending adventure, danger, and the pioneering spirit of those who shape the frontier.”)

Expanding into new territory is always challenging and perilous, especially for heavily regulated industries. With new AI capabilities and tools cropping up regularly and every industry trying to figure out the best way of harnessing them, pharma marketers have been advancing into AI cautiously.

Social media analysis is one of the first areas where the industry began successfully using AI tools. This involves extracting information and deriving insights from user-generated content across all major social media platforms globally. Using AI models enables pharma companies to identify trends with unprecedented scope and speed and gain real-time insights into public sentiment and patient needs.

As pharma marketers continue assessing AI and its significant opportunities, following are some important ways AI can be used to enhance DTC marketing.

  • Getting Personal: Personalized marketing is a key area where AI-based research models provide great value. Using AI tools to evaluate a variety of data – including social media engagement, click-through, and bounce rates – gives DTC marketers a deeper understanding of the patient journey and the touchpoints and issues that impact it. Ultimately, this information can drive more sophisticated targeting strategies and more relevant, personalized messaging. It also helps marketers anticipate market shifts more quickly and be more agile and focused in responding to them.
  • Growing Sentimental: Using AI to analyze unfiltered customer feedback on social media and review platforms gives DTC brands the ability to proactively address patient concerns and urgent issues. For example, a Facebook user posting a question about a new drug may immediately get hundreds or even thousands of comments addressing the query. An AI-powered tool can evaluate the posts in real time, assess opinions expressed, indicate misperceptions, and flag commentaries that require a proactive reply.  AI-assisted sentiment analysis can also identify what social media groups and influencers are developing around a specific disease state or drug. This enables pharma marketers to provide more relevant content, helping to increase conversion rates.
  • Correction Please! AI models are also useful in stopping the spread of misinformation and disinformation. By rapidly evaluating huge data sets and targeting the origins of bad information in real time, AI enables pharmaceutical companies to respond to misinformation both quickly and directly at its sources. This, in turn, can help companies correct the record and establish greater trust in their brands. Imagine if AI had been further developed during the pandemic to respond to the disease and vaccine misinformation prevalent at that time.

 

While the sophistication and accessibility of AI tools are thrilling, DTC marketers still need to balance traditional market research with AI-led models. Traditional market research generates large volumes of in-depth information, but that data is very time-consuming to analyze and limited in scope. AI-driven research is fast and broad in scope, but still subject to bias and misinterpretation in some areas, e.g., it can misinterpret sarcasm or context-specific nuances, which may skew results. The best approach for DTC marketers is to identify and verify where AI-driven research can most effectively complement traditional research and develop an integrated strategy that optimizes both.

While we don't know what the next election will bring, we do know that privacy and governance in AI will be on the table. Pharmaceutical companies and their agencies must develop their use of AI within a strong data-governance framework, always asking themselves what the ethical boundaries of AI are and how data privacy and online patient information can be protected. Without this focus on privacy and governance, the industry risks major setbacks and penalties in its adoption of AI. Protecting the autonomy and privacy of the individual remains paramount.

Ultimately, the goal of using AI in DTC marketing is to help consumers better understand their health, the diseases that affect their health, and the options available for preventing, managing and treating those diseases. With imagination, skill, and proper guardrails and compliance, AI could well usher in a transformative new era in DTC marketing.

Sharlene Jenner

bigstock-Female-Cardiologist-In-Coat-Ta-476618381-1200x801.jpg
Guest ColumnistXpectives.Health in Focus

Women’s Health: 5 Trends to Watch for in 2024

March 22, 2024 0

ECG keeps a watchful eye on trends in women’s health. In 2023 we saw a birth rate that stabilized overall, with variability at local levels; unit closures; growing demand for high-risk services; and provider shortages. Will those trends continue in the new year?

Here are five key drivers that we expect to shape women’s health services in 2024.

  1. Consolidation, Closures, and Growing Maternity Deserts

ECG has written on OB unit closures and the resulting maternity deserts, which are largely driven by industry-wide staffing shortages and pressure on health systems to remain financially sustainable. This year, we foresee an increase in provider group consolidation as OB/GYNs seek relief from burdensome call demands. Impacts to patient access will be substantial; limited resources will be focused on the necessary coverage of inpatient services, to the detriment of outpatient care.

Implication: This is an opportunity for providers to differentiate themselves in their markets and serve their communities in new ways, such as reimaginging care team structure/roles, seeking new partners, embracing innovation, and enhancing operational efficiency.

  1. The Rise of Care Teams

As physician recruitment becomes more challenging and financial headwinds mount, successful women’s health programs are approaching care teams from a holistic perspective. To create the most efficient care model, health systems are partnering with obstetricians, midwives, doulas, physical therapists, and APPs to form teams that promote an expanded scope of services to meet patient preferences while allowing each team member to practice at the top of their license. These team-based models offer many advantages, including:

  • Expanded access through greater coverage and schedule availability.
  • More effective and culturally competent care delivery.
  • Increased patient and workforce satisfaction.

Implication: Creating a care model that coordinates and effectively communicates activities across functions and team members is key to overall program success. Identifying governance, span of control, and agreed-upon care standards is essential to ensuring quality is maintained while care models evolve. The consensus-building process is the most critical component to this type of work, so proper staff and provider involvement is imperative.

  1. Investment in Women’s Health

Market fragmentation, enhanced consumerism, and rise in overall demand for women’s health offerings has drawn the attention of private equity (PE) investors. Investment in women’s health services has more than tripled in recent years, and more deals are anticipated in 2024 as venture capitalists see opportunities in areas such as fertility/reproductive health, menopausal medicine, coordinated pregnancy care, and postpartum recovery. Investment drives innovation, as seen by the multitude of new technologies and services emerging in the women’s health sector. Depending on the perspective, specific investments may be considered a welcome addition or additional hurdle for providers.

  • New care models offer opportunities for diversification for systems looking to expand their offerings with fewer resources. Apps, digital patient education, home monitoring, and virtual services augment the traditional patient care experience.
  • Women’s health is becoming an increasingly competitive space. New service provider entrants to the market offer medical services to niche patient populations, potentially siphoning patients who may otherwise have sought services from existing providers and facilities.

Implication: Rapid innovation and technology gives providers an opportunity to differentiate their offerings. Providers should be watchful of the investments in women’s health and consider the impacts to their organizations. As PE investment expands, most health systems will have to make a choice: compete directly with PE-backed companies through targeted alignment, acqusition, and investment in incubator spaces, or partner with PE firms in a structure that maximizes capital investment and the system’s own management expertise.

  1. Focus on Quality and Access

The maternal mortality rate continues to rise, particularly for women of color. In 2022, the White House released a Blueprint for Addressing the Maternal Health Crisis, which puts an increased focus on addressing quality and access challenges for maternal care. The report recommends several initiatives—including an expansion of programming, an increase in price transparency, and the “Birthing-Friendly” designation—that will shape the future of women’s healthcare services by holding facilities accountable.

Implication: Strategies to support operational efficiencies (particularly around outcomes) will be imperative to remaining competitive. Providers and facilities should consider targeted investments, establish transparent communication/marketing positioning, and optimize outpatient operations to remain financially sustainable.

  1. Changing Regulatory and Legislative Landscape

Providers face a fluid regulatory and legislative landscape, which will continue to impact access to services as well as the cost of doing business.

  • Reproductive Health: Access and regulations have changed on a state-by-state basis, potentially shifting the provision of services and resulting risk. Structuring meaningful care pathways will help organizations to maintain quality and outcomes while mitigating risks.
  • Malpractice Costs: Costs for malpractice insurance are already among women’s health providers’ greatest expenses, and obstetricians are the most likely of all physicians to be sued for malpractice. While malpractice caps help balance providers’ risk, several states are proposing increases to those caps—which would heighten financial risk for providers. This may prove to be a driver of change among provider groups, adding pressure to consolidate practices, discontinue services, or retire earlier in an effort to reduce risk exposure and expenses.
  • Chaperone Laws: State requirements for chaperoning physical exams vary, but women’s health providers are the most impacted. These laws continue to evolve—as is evident from recent legislation in Oregon and Wisconsin—and have the potential to impact business operations via staffing and workflow adjustments.

Implication: For many providers and facilities, women’s health is a core service—a foundational offering that must be provided regardless of the constraints. The key will be the ability to shift through changes and create operations that will enable healthcare providers to remain sustainable—and potentially grow—in an uncertain environment.

Tessa Kirby

Older Posts