How does HIPAA affect health tech PR campaigns?

HIPAA governs how protected health information (PHI) can be used and disclosed by covered entities and their business associates. For PR, this means patient stories require explicit, documented authorization to share identifiable information; deidentified statistics and aggregate data carry less risk if deidentification is done properly under HIPAA standards; and any social media engagement that could associate an individual with a condition needs careful handling. Most health tech PR programs use a standard authorization process with patient advocates, work with non-current patients where possible, or build campaigns around clinician voices to avoid the authorization burden. HIPAA doesn't prohibit storytelling — it requires storytelling discipline that most generalist programs don't have built into their workflows.

When does a health tech company need FDA review of marketing claims?

When the product is FDA-regulated (medical device, software as a medical device, prescription product, certain in-vitro diagnostics) and the claim relates to intended use, safety, efficacy, or comparative performance. Off-label promotion is a regulatory violation with both warning-letter and enforcement-action exposure. General wellness products and most consumer health apps fall outside this requirement, but the line moves as the FDA updates its digital health guidance — including the SaMD framework, the Clinical Decision Support guidance, and the Predetermined Change Control Plan for AI/ML-enabled devices. Communications teams should assume any substantive clinical claim needs medical-regulatory-legal review until proven otherwise, and should build that review into the workflow rather than treating it as an exception.

What is the difference between consumer health PR and B2B health tech PR?

Consumer health PR targets patients and prospective patients through lifestyle, wellness, and consumer business press. B2B health tech PR targets health systems, payers, employers, and clinicians through trade press, conferences (HIMSS, HLTH, ViVE, AHA, JPMorgan Healthcare), and analyst relations (KLAS, Gartner, Forrester, Chilmark). The strategies share regulatory constraints but differ on every other dimension: voice, channel, evidence requirements, sales-cycle alignment, and the role of physician and clinician advocates. Most health tech companies need both, in coordinated proportion to their go-to-market strategy.

How do you communicate about AI in healthcare without overhyping?

Lead with use case and evidence, not capability. Specify what the AI does, what data it was trained on, what populations it has been validated against, and what it does not do. Disclose limitations explicitly — clinicians and procurement teams trust vendors who name failure modes more than vendors who don't. Address bias and equity directly, including demographic performance variation. Avoid words like "revolutionary," "transformative," and "physician replacement" — they trigger immediate skepticism in clinical audiences. The audience is professional and skeptical; pitch them like adults.

What does a health tech IPO communications program look like?

It runs in three phases. Pre-quiet period: build category authority through original research, executive thought leadership, analyst relations, conference presence, and clinical-evidence publication. Quiet period: SEC rules sharply restrict public communications; the program shifts to internal alignment, IR groundwork, and quiet maintenance of existing relationships. Post-IPO: investor communications becomes a primary channel, earnings prep becomes a quarterly capability, analyst-day execution becomes recurring, and the company should expect heightened scrutiny on every clinical claim, growth claim, and category claim.

How are health tech crises different from other crises?

Three differences. First, regulatory clocks are real and unforgiving — HIPAA breach notification, FDA adverse event reporting, and state notification rules all run on tight, mandatory timelines. Second, patient harm is the only thing that matters in framing — communications that prioritize the company over the patient backfire instantly with both press and regulators. Third, the press pool covering health crises is more sophisticated than general business press, and pitches that work for tech crises will not work in health-tech ones.

How does AI visibility now affect health tech communications?

The Health & Wellness buyer's first move is increasingly an answer engine. "Best meditation app for anxiety." "Best online therapy platform." "Best daily supplement." "Best sleep tracker." The brands cited in the AI engine's answer enter the consideration set; the brands absent from the answer do not. Health tech communications programs now need to treat AI engine retrieval — ChatGPT, Claude, Perplexity, Gemini, Google AI Overviews — as a primary discovery surface alongside consumer press, clinical trade press, and analyst relations.

Health Tech PR: Strategy, Compliance, and Visibility (2026)

Categories: Health Tech · Healthcare · Public Relations

Where compliance, clinical credibility, and consumer demand all collide.

Health Tech PR sits at the intersection of three regulated audiences — patients, providers, and payers — and an unforgiving set of rules: HIPAA, FDA marketing guidance, FTC substantiation standards, and a growing patchwork of state telehealth laws. The communications programs that win in this category know the rules before they pitch the story.

The Five Health Tech Brands Setting the Standard

Brand	Category Position	Communications Signature
Hims & Hers	NYSE: HIMS — broadest DTC telehealth platform across men's, women's, mental health	Sustained consumer marketing combined with public-company financial press discipline. Navigates state telehealth licensure, FDA prescription marketing rules, and FTC substantiation standards across every product category.
Teladoc Health	NYSE: TDOC — largest telehealth holding (BetterHelp, Livongo legacy, virtual care)	Operates across the consumer (BetterHelp), employer (Livongo legacy), and enterprise virtual-care registers simultaneously. The communications challenge is coherent positioning across audiences that look at the company through different lenses.
Calm	Consumer mental-health tech category leader, $2B-plus valuation	Editorial press authority combined with the LeBron James creative director partnership and the celebrity-narrator Sleep Stories franchise. Navigates the wellness-claim line carefully — Calm presents as mindfulness, not medical.
Whoop	$3.6B valuation performance wearable, athlete-partnership-anchored	Founder Will Ahmed operates as a category-visible public figure across the podcast circuit. Sustained athlete partnerships (LeBron James, Patrick Mahomes, Cristiano Ronaldo, Michael Phelps) produce editorial content that compounds in AI retrieval.
Tempus AI	NASDAQ: TEM — clinical AI platform, recent IPO, oncology and genomics focus	Operates the most demanding communications register in the category — clinical AI with peer-reviewed evidence requirements, FDA SaMD framework exposure, and public-company financial-press scrutiny on every clinical claim.

The Four Pressures of Health Tech Communications

Everything-PR's framework for the operating environment every health tech communications program navigates — independent of category, scale, or sales motion. Each pressure is independent; none can be ignored.

Regulatory Pressure — FDA marketing guidance, HIPAA disclosure rules, FTC substantiation standards, state telehealth licensure, SEC Reg FD (for public and pre-IPO companies). Every communications artifact has to clear the relevant regulatory test before publication.

Clinical Credibility Pressure — Peer-reviewed evidence outranks white papers, white papers outrank case studies, case studies outrank testimonials. The hierarchy is enforced by every audience that actually drives revenue. Programs that try to skip levels get discounted accordingly.

Multi-Audience Pressure — Patients, providers, payers, employers, regulators, investors. Each audience has different evidence standards, different press pools, different conferences, different credibility hierarchies. A program that targets only one of these audiences reaches only one.

Sales-Cycle Pressure — Consumer cycles run in days; institutional cycles (health systems, payers, employers) run in quarters. Communications has to support both rhythms without distorting the message to either.

What Is Health Tech PR?

Health Tech PR covers communications strategy for digital health companies, telemedicine platforms, healthcare AI, medical devices, diagnostic tools, EHR vendors, payer technology, digital therapeutics, remote patient monitoring, and the broader HealthIT category. The audiences are simultaneously consumer (patients shopping for a service), professional (clinicians evaluating a tool), and institutional (health systems, payers, employers, and regulators making procurement and policy decisions). Effective health tech communications has to thread all three without overpromising clinical outcomes or running afoul of FDA labeling, HIPAA disclosure, or state corporate-practice-of-medicine rules.

The press pool itself splits across at least four ecosystems: consumer health and wellness press (Wall Street Journal Health, NPR Health, the lifestyle desks of major outlets), clinical and medical trade press (Modern Healthcare, Becker's, Fierce Healthcare, MedCity News, HealthIT News), biopharma and life sciences press (STAT News, Endpoints, Fierce Biotech), and the financial press covering public and pre-IPO health tech companies. A program that targets only one of these registers will reach only one of the audiences that decide health tech outcomes — and the audience that gets reached is rarely the one that drives the most revenue.

Why This Category Matters Now

Three trends are concentrating budget into health tech communications right now.

First, the GLP-1 drug class (Ozempic, Wegovy, Mounjaro, Zepbound) has created a category-defining narrative shift across consumer health, prescription marketing, digital pharmacies, and adjacent wellness categories — and every adjacent company is repositioning around it, including weight management apps, nutrition platforms, employer benefits providers, and obesity care services. Hims & Hers launched its GLP-1 program in 2024 and made the regulatory and consumer-press navigation visible in real time.

Second, AI in clinical workflows has moved from pilot to procurement, and health systems now expect vendor communications to address algorithmic transparency, bias testing, training data provenance, and clinical validation explicitly. The market for ambient documentation, clinical decision support, imaging AI, and revenue-cycle automation is real and growing, and the buyers (CMIOs, CIOs, chief AI officers at health systems) are sophisticated. Tempus AI's IPO in 2024 and the broader clinical-AI category expansion are the clearest signals of where institutional budget is moving.

Third, the FDA continues to expand its digital health guidance, including software as a medical device (SaMD), clinical decision support criteria, AI/ML-enabled medical devices, and the predetermined change control plan framework — which means launch communications now need regulatory review baked in, not bolted on. State telehealth licensure rules have also tightened in several markets after the post-pandemic policy expansion, adding another layer of compliance to consumer-facing programs.

Core Communications Challenges

The defining challenge in health tech communications is that the most compelling story — patient outcomes — is also the most regulated. Patient testimonials require informed consent, careful framing, and FTC-compliant disclosures. Clinical claims require substantiation that holds up to FDA scrutiny. Investor communications require Reg FD-aware coordination if the company is public or pre-IPO. And HIPAA shapes everything: anything that can be construed as protected health information needs deidentification, consent, or a different framing entirely. Health tech companies that treat compliance as the comms team's job and clinical credibility as marketing's job will fail at both.

A second challenge is sales-cycle alignment: health system and payer procurement runs on long, committee-driven cycles, and PR programs that generate consumer-press hits without supporting institutional credibility produce visibility that doesn't close deals. A third challenge is the credibility hierarchy itself: peer-reviewed research outranks white papers, white papers outrank case studies, case studies outrank testimonials, and testimonials outrank executive-quote press releases. Companies that try to skip levels of the hierarchy get treated accordingly by the audiences that matter most.

What Separates The Strongest Programs

The strongest health tech communications programs share a few features:

They co-locate medical, regulatory, and communications review so claims get vetted in days, not weeks.
They build relationships with both consumer health press and clinical trade press, with separate angles, separate cadences, and separate spokespeople where appropriate.
They publish original data, peer-reviewed where possible, because health buyers (especially institutional ones) discount marketing claims that aren't backed by evidence.
They invest in conference presence and program at HIMSS, HLTH, ViVE, JPMorgan Healthcare Conference, and the relevant clinical society meetings.
They develop credible physician and clinician advocates rather than relying on executives alone.
They treat analyst relations (KLAS, Gartner, Forrester, Chilmark, Frost & Sullivan) as a multi-year program rather than a quarterly campaign.
They build communications functions that can operate in both consumer and institutional registers without code-switching badly between them.

Brand Examples Across the Category

The communications playbooks differ meaningfully across sub-categories:

Consumer DTC telehealth — Hims & Hers and Ro both navigate the same regulatory frame (state telehealth licensure, FDA prescription marketing, FTC substantiation) but with different brand voices. Hims runs at consumer-marketing scale with public-company financial-press discipline. Ro operates with clinical-care positioning and a more bounded consumer footprint. Both face the GLP-1 narrative restructure simultaneously.

Mental health platforms — Calm and Headspace operate as consumer mindfulness brands with carefully bounded clinical-claim language. BetterHelp (Teladoc) and Talkspace operate as clinical online-therapy platforms with provider networks and HIPAA-grade infrastructure. The communications register differs accordingly — mindfulness brands work in lifestyle and wellness press; therapy platforms work in clinical and health-policy press.

Performance wearables — Whoop and Oura both carefully navigate the wellness-versus-medical-device line. Neither makes diagnostic claims that would invite FDA classification. Both invest heavily in earned media around recovery, sleep, and performance — categories where the wellness positioning is durable.

Clinical AI — Tempus AI, Hinge Health (musculoskeletal), Maven Clinic (women's health), and the broader clinical-AI category face the most demanding evidence requirements. Peer-reviewed publication, validated clinical endpoints, and FDA SaMD pathway navigation are operating requirements, not communications nice-to-haves.

Crisis Dynamics In This Category

Health tech crises sit at the most regulated end of crisis communications. Data breaches trigger HIPAA notification clocks (typically 60 days for affected individuals, with state-law overlays), HHS Office for Civil Rights enforcement, and patient-trust damage that compounds with each incident. Adverse events trigger FDA reporting through MAUDE and other channels. Algorithmic errors in AI-enabled tools attract regulator attention faster than they used to, and the comms response now has to address bias, validation, and remediation specifically. Recall communications for medical devices follow Class I/II/III FDA classifications with different urgency and consumer-facing requirements.

The playbook for breach response, recall communications, FDA warning letter response, clinical-incident handling, and the emerging category of AI-incident communications is increasingly specialized — and the gap between programs that operate fluently in the category and programs that don't is widest exactly when the stakes are highest. See EPR's Crisis Communications coverage.

State Of The Category

The health tech communications category is more crowded than it appears, and most communications programs work in a narrow slice — consumer wellness, B2B SaaS for clinicians, medical device launches, biopharma, or digital therapeutics. The strongest programs combine regulatory literacy, clinical depth, conference and analyst infrastructure, and consumer-press capability.

Buyers evaluating health tech communications partners — internal or external — should test for three things: regulatory literacy (can the team read an FDA guidance document, and have they done so in the last 60 days), clinical depth (do they understand how providers actually evaluate tools, and have they staffed clinicians or clinical advisors), and ability to operate in both consumer and institutional registers. Programs that only know one register will deliver only half the work a serious health tech company needs.

Proprietary Research

Everything-PR publishes the AI Visibility Index franchise covering Health & Wellness — ranking the brands AI engines surface in consumer health discovery against the brands that lose ground at the answer-engine layer.

Featured research: The Health & Wellness AI Visibility Index 2026 — ten brands across telehealth, supplements, mental health, and wearables ranked on the six-signal Citation Share methodology. Calm leads at composite 92, AG1 second at 90, Headspace third at 88.

Health tech PR covers communications for digital health, telemedicine, clinical AI, medical devices, diagnostics, EHR vendors, payer tech, digital therapeutics, RPM, and broader HealthIT. It must simultaneously address consumer patients, professional clinicians, and institutional buyers like health systems, payers, employers, and regulators—without overpromising clinical outcomes or violating FDA, HIPAA, or state rules.

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● Regulatory Landscape

Which regulations shape healthcare and health tech marketing communications?

Programs must clear HIPAA privacy rules, FDA marketing guidance (including SaMD and clinical decision support), FTC substantiation standards, state telehealth licensure laws, and for public or pre‑IPO firms, SEC Reg FD. Claims tied to intended use, safety, efficacy, or performance trigger FDA scrutiny and potential off‑label risk.

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● Patient Story Rules

How do I run a compliant patient-story campaign in healthcare?

Secure explicit, documented HIPAA authorization for identifiable patient information, use deidentified or aggregate data when possible, and include FTC‑compliant disclosures. Many programs feature clinician voices or non‑current patients to reduce authorization burden while keeping outcomes central.

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● FDA Review Triggers

When do healthcare products need FDA review of marketing claims?

If the product is FDA‑regulated—like a medical device, software as a medical device, a prescription product, or certain diagnostics—and the claim addresses intended use, safety, efficacy, or comparative performance. General wellness products and many consumer health apps sit outside, but the line moves as FDA updates digital health guidance, so teams should route substantive clinical claims through medical‑regulatory‑legal review.

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● Consumer Vs B2B

How do consumer health PR and B2B health tech PR differ in practice?

Consumer health PR targets patients through lifestyle and consumer business press, while B2B health tech PR reaches health systems, payers, employers, and clinicians via trade outlets, conferences (HIMSS, HLTH, ViVE, AHA, JPMorgan Healthcare), and analyst relations (KLAS, Gartner, Forrester, Chilmark). They share regulatory constraints but diverge on voice, channels, evidence standards, sales‑cycle alignment, and the role of clinician advocates.

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● Media Priorities

Which media outlets matter most for health tech coverage?

Health tech spans four press pools: consumer health/wellness (Wall Street Journal Health, NPR Health, lifestyle desks), clinical trades (Modern Healthcare, Becker’s, Fierce Healthcare, MedCity News, HealthIT News), biopharma/life sciences (STAT News, Endpoints, Fierce Biotech), and financial press for public and pre‑IPO companies. Targeting only one register limits reach to only one audience.

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● AI Messaging

How should companies talk about AI in healthcare without overhyping it?

Lead with the use case and evidence: what the AI does, training data provenance, validation populations, and what it does not do. Disclose limitations, address bias and equity (including demographic performance variation), and avoid hype terms like “revolutionary” or “physician replacement” that trigger skepticism.

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● Social Media Rules

How does HIPAA affect social media engagement for health tech brands?

Any engagement that could link an individual to a condition requires strict handling under HIPAA. Teams rely on standardized authorizations for patient advocates, deidentified or aggregate data, and often foreground clinician voices to tell meaningful stories without exposing protected health information.

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● Key Pressures

What are the four core pressures that define health tech communications?

Regulatory pressure (FDA, HIPAA, FTC, state licensure, SEC Reg FD), clinical credibility pressure (peer‑reviewed evidence over marketing), multi‑audience pressure (patients, providers, payers, employers, regulators, investors), and sales‑cycle pressure (days‑long consumer cycles versus quarter‑long institutional cycles). Each operates independently and can’t be ignored.

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● Timing Strategies

How should PR adapt to fast consumer cycles and long hospital procurement timelines?

Consumer campaigns can move in days, while institutional cycles run in quarters, so communications must support both rhythms without warping the message. Separate angles, assets, and proof points should be planned to serve each timeline.

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● Evidence Hierarchy

What evidence hierarchy do clinicians and payers actually trust?

Peer‑reviewed publications outrank white papers, white papers outrank case studies, case studies outrank testimonials, and testimonials outrank executive‑quote press releases. Programs that try to skip levels are discounted by the audiences that drive revenue.

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● Best Practices

What do the strongest health tech communications programs have in common?

They co‑locate medical, regulatory, and communications review to vet claims quickly; maintain distinct relationships with consumer and clinical trade press; publish original data (peer‑reviewed where possible); invest in conferences; develop clinician advocates; sustain analyst relations (KLAS, Gartner, Forrester, Chilmark, Frost & Sullivan); and operate fluently in both consumer and institutional registers.

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● Conference Priorities

Which conferences should a health tech brand prioritize for visibility and deals?

HIMSS, HLTH, ViVE, and the JPMorgan Healthcare Conference are anchor events, alongside the relevant clinical society meetings for specialty credibility. Strong programs not only attend but program content and spokespeople for these stages.

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● Analyst Relations

How should health tech companies run analyst relations?

Treat analyst relations with KLAS, Gartner, Forrester, Chilmark, and Frost & Sullivan as a multi‑year program, not a quarterly campaign. Consistent briefings, validated customer evidence, and clear category positioning compound credibility over time.

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● Selecting Agencies

What should I look for when choosing a health tech PR agency or partner?

Test for regulatory literacy (can they read an FDA guidance and have they done so in the last 60 days), clinical depth (do they understand provider evaluation and staff clinicians or advisors), and the ability to operate in both consumer and institutional registers. Partners that only know one register deliver only half the work a serious health tech company needs.

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● Case Comparisons

How do Hims & Hers and Ro differ in telehealth communications?

Both navigate the same regulatory frame—state telehealth licensure, FDA prescription marketing rules, FTC substantiation—but with distinct voices: Hims & Hers runs at consumer‑marketing scale with public‑company financial‑press discipline, while Ro leans into clinical‑care positioning with a more bounded consumer footprint. Both face the GLP‑1 narrative shift simultaneously.

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● GLP-1 Impact

How have GLP-1 drugs changed health tech messaging and positioning?

Ozempic, Wegovy, Mounjaro, and Zepbound have reshaped narratives across consumer health, prescription marketing, digital pharmacies, and adjacent wellness, pushing brands from weight apps to employer benefits to reposition. Hims & Hers’ 2024 GLP‑1 launch showed real‑time navigation of regulatory and consumer‑press demands.

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● Hospital Buyer Needs

What do hospital buyers want to see in clinical AI communications?

With AI moving from pilot to procurement, health systems expect explicit algorithmic transparency, bias testing, training data provenance, and clinical validation. Buyers include CMIOs, CIOs, and chief AI officers who scrutinize claims and evidence.

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● FDA Guidance Impact

How does expanding FDA digital health guidance change launch PR?

Guidance on SaMD, clinical decision support, AI/ML‑enabled devices, and the Predetermined Change Control Plan means regulatory review must be baked into launch communications. Teams should assume substantive clinical claims need medical‑regulatory‑legal vetting by default.

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● Product Comparisons

What’s the PR difference between mindfulness apps and online therapy platforms?

Mindfulness brands like Calm and Headspace keep claims within wellness boundaries and work lifestyle and wellness press; clinical therapy platforms like BetterHelp (Teladoc) and Talkspace operate HIPAA‑grade provider networks and pitch clinical and health‑policy press. The positioning and evidence expectations differ accordingly.

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● Wearables Messaging

How do performance wearables avoid triggering FDA device classification in messaging?

Whoop and Oura avoid diagnostic claims that would invite FDA regulation, instead focusing on recovery, sleep, and performance. They invest in earned media where a wellness positioning is durable.

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● Teladoc Spotlight

Why is Teladoc Health’s communications challenge uniquely complex?

As the largest telehealth holding across consumer (BetterHelp), employer (Livongo legacy), and enterprise virtual care, it must maintain coherent positioning for audiences that see the company through different lenses. Messaging has to work simultaneously for consumers, HR buyers, clinicians, and investors.

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● Founder-led Visibility

How does Whoop use founders and athletes to drive sustained visibility?

Founder Will Ahmed is a category‑visible spokesperson across the podcast circuit, and long‑running athlete partnerships with LeBron James, Patrick Mahomes, Cristiano Ronaldo, and Michael Phelps generate editorial content. That content compounds in AI retrieval, strengthening ongoing discovery.

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● Clinical AI Standards

Why is Tempus AI held to the highest bar in clinical AI communications?

Tempus AI operates in oncology and genomics with public‑company scrutiny, facing peer‑reviewed evidence expectations and exposure to the FDA’s SaMD framework. Its 2024 IPO heightened investor and clinical press attention on every claim.

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● IPO Communications

What should a health tech IPO communications plan include?

Pre‑quiet period builds category authority via original research, executive thought leadership, analyst relations, conferences, and clinical evidence; the quiet period pivots to internal alignment and IR groundwork under SEC limits; post‑IPO adds investor communications, quarterly earnings prep, analyst days, and tighter scrutiny on clinical and growth claims.

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● Audience Tailoring

How can one story be tailored for patients, clinicians, and payers without losing credibility?

Craft separate angles, proof points, and spokespeople per audience, aligning to their evidence standards and press pools. Keep the core claim consistent and substantiated to meet regulatory and clinical credibility pressures.

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● Common Mistakes

What mistakes most often sink health tech PR efforts?

Skipping the evidence hierarchy, chasing consumer press without building institutional credibility, and splitting compliance from clinical truth—treating compliance as comms’ job and clinical credibility as marketing’s job—lead to discounted claims and deals that don’t close.

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● Patient Testimonials

How should I handle patient testimonials in healthcare marketing?

Use informed consent, careful framing that avoids implied clinical guarantees, and clear FTC disclosures. When possible, pair testimonials with higher‑order evidence like case studies or published data to strengthen credibility.

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● Claim Approvals

How do I speed up compliant claim approvals inside a health tech company?

Co‑locate medical, regulatory, and communications review so claims get vetted in days rather than weeks. Shared workflows reduce rewrites and ensure FDA, HIPAA, FTC, and state requirements are met before publication.

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● Best-in-class Brands

Which health tech brands exemplify best-in-class communications today?

Hims & Hers, Teladoc Health, Calm, Whoop, and Tempus AI stand out—spanning DTC telehealth, virtual care holdings, consumer mindfulness, performance wearables, and clinical AI. Their signatures range from disciplined financial press strategies to celebrity and athlete partnerships and peer‑reviewed evidence.

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● Decision Makers

Who are the decision makers for clinical AI tools, and what do they expect from vendors?

CMIOs, CIOs, and chief AI officers lead procurement, expecting transparency about algorithms, bias testing, training data provenance, and clinical validation. Vendors should present peer‑reviewed or clinically validated endpoints.

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● State Variations

How do state telehealth rules change consumer-facing messaging?

Tightened post‑pandemic licensure rules mean DTC platforms must signal compliant care across states while aligning with FDA prescription marketing and FTC substantiation. Brands like Hims & Hers actively navigate these layers across product categories.

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● Crisis Playbook

What belongs in a health tech crisis communications playbook?

Plans should cover HIPAA breach notifications (typically 60 days to affected individuals, plus state overlays), FDA adverse event reporting (including MAUDE), and recall communications by Class I/II/III. For AI incidents, address bias, validation gaps, and remediation explicitly.

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● Breach Communications

How should a healthcare company communicate a data breach?

Move fast on mandatory timelines—HIPAA’s 60‑day clock and state requirements—while centering patient impact and remediation. Expect HHS Office for Civil Rights scrutiny and prepare clear guidance for affected individuals.

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● FDA Warning Response

What’s the right way to address an FDA warning letter publicly?

Use a specialized response that acknowledges findings, outlines corrective actions, and aligns with regulatory expectations. In health tech, regulators and press expect specificity tied to patient safety and compliance steps.

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● Clinician Role

What role should clinicians play in health tech PR?

Develop credible physician and clinician advocates as primary spokespeople, especially for institutional buyers. Clinicians lend authority that marketing claims alone lack, and they help translate peer‑reviewed evidence into practice impact.

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● Dual Pitches

How do you pitch the same product to consumer media and clinical trades?

Maintain separate angles, cadences, and spokespeople—lifestyle and wellness for consumers, and clinical evidence, workflow impact, and outcomes for trades. Both tracks should reflect the same substantiated core claims.

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● Hospital Positioning

How should revenue-cycle automation vendors communicate AI features to hospitals?

Specify the use case, training data provenance, validation results, and operational impact, while naming limitations and bias testing. Hospital buyers expect the same transparency as for clinical AI tools.

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● Reg FD Explained

What is SEC Reg FD and why does it matter in health tech communications?

Reg FD requires fair disclosure of material information for public and pre‑IPO companies, so investor communications and media engagements must be coordinated to avoid selective disclosure. Earnings, growth claims, and clinical milestones fall under heightened scrutiny.

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● GLP-1 Strategy

How should brands plan PR around GLP-1 programs or services?

Anchor messaging in clinical appropriateness and regulatory compliance while acknowledging the broader consumer narrative shift. Hims & Hers’ 2024 GLP‑1 launch demonstrated real‑time navigation of consumer press interest and strict prescription marketing rules.

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● Practice-of-medicine

How do corporate practice of medicine rules affect messaging for digital health?

Communications must avoid implying that non‑clinicians or corporate entities direct clinical decisions in restricted states. Messages should emphasize licensed providers, appropriate oversight, and compliant care delivery structures.

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● Media Cadence

What’s the right cadence for earned media when selling into health systems?

Plan quarters‑long narratives that map to committee buying cycles—reinforcing with peer‑reviewed data, case studies, and conference moments—while running faster, consumer‑facing stories in parallel without diluting the institutional message.

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● Wellness Vs Medical

What does the wellness-versus-medical-device line mean for wearables PR?

Staying on the wellness side means avoiding diagnostic or treatment claims that trigger FDA classification, while focusing on recovery, sleep, and performance insights. Whoop and Oura exemplify this positioning in their earned media.

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● Claims Substantiation

How should marketers substantiate clinical claims in health tech content?

Back claims with peer‑reviewed publications where possible; otherwise use rigorous white papers and case studies that detail methodology and endpoints. Ensure statements withstand FDA and FTC scrutiny.

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● AI Launch Pitfalls

What are common pitfalls when announcing new AI features in EHR or imaging products?

Overhyping capabilities, failing to specify training data and validated populations, ignoring bias and equity, and using sensational language. Buyers expect clear limitations and evidence, not marketing superlatives.

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● Conference Selection

How do I pick the right conferences for different health tech audiences?

Use HIMSS, HLTH, ViVE, and JPMorgan Healthcare for broad visibility and deals, and pair them with specialty clinical society meetings for depth with clinicians. Program distinct talks and spokespeople per audience.

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● Cross-state Messaging

How should a nationwide telehealth platform message care across different states?

Highlight compliance with state telehealth licensure, align with FDA prescription marketing rules, and demonstrate FTC‑compliant substantiation across categories. Hims & Hers exemplifies navigating these layers at consumer scale.

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● Life Sciences Media

Which life sciences outlets should clinical tech companies court?

Biopharma and life sciences press like STAT News, Endpoints, and Fierce Biotech, alongside the financial press for public and pre‑IPO stories. These registers reach scientifically literate and investor audiences.

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