HIPAA
PHI protection, BAAs, audit trails
Clinical Workflows
EHR integration, care coordination
Patient Safety
Error prevention, alert fatigue, dosing
Interoperability
HL7 FHIR, DICOM, data exchange
In HealthTech, "move fast and break things" doesn't apply — patient safety comes first
What is HealthTech Product Management?
HealthTech Product Management is the discipline of building technology products that improve health outcomes, healthcare delivery, or healthcare operations. This includes everything from telehealth platforms and electronic health records to medical devices, digital therapeutics, and clinical AI.
What makes HealthTech unique is the stakes: these products can directly impact patient health and safety. A bug in a consumer app is an inconvenience; a bug in a clinical decision support system could lead to misdiagnosis. This responsibility shapes every product decision.
The regulatory environment is complex—HIPAA, FDA, state laws—but it exists to protect patients. Great HealthTech PMs view compliance not as a burden but as a feature that enables trust and adoption.
HealthTech Verticals
HealthTech spans multiple verticals, each with unique challenges:
Telehealth
Virtual care delivery and remote consultations
EHR/EMR
Electronic health record systems
Digital Therapeutics
Software as treatment for medical conditions
Medical Devices
Connected devices and wearables for health
Healthcare Admin
Billing, scheduling, and operations software
Clinical AI
AI-assisted diagnosis and decision support
Key Regulations for HealthTech PMs
HIPAA
Protects patient health information (PHI)
PM Implication: Encrypt data, access controls, audit logs, BAAs with vendors, breach notification
FDA Regulations
Regulates medical devices including software
PM Implication: Determine if your product is a medical device; if so, navigate 510(k), De Novo, or PMA pathway
HITECH
Promotes EHR adoption and strengthens HIPAA
PM Implication: Meaningful Use requirements, health information exchange, breach notification rules
State Regulations
State-specific healthcare and privacy laws
PM Implication: Telehealth licensing varies by state, some states have stricter privacy laws
GDPR (EU)
Data protection for EU citizens
PM Implication: Health data is special category—extra protections, explicit consent, DPO requirements
21 CFR Part 11
Electronic records and signatures
PM Implication: If FDA-regulated, electronic signatures and audit trails must meet specific standards
Patient Safety First
When in doubt, err on the side of patient safety. Regulations exist because healthcare technology can cause real harm. If you're unsure whether something is safe, don't ship it. Consult clinical advisors, regulatory experts, and your conscience.
Healthcare Stakeholders
Healthcare has a uniquely complex stakeholder landscape. Understanding each group is essential:
Patients
The people receiving care. They want: easy access to care, understanding of their health, control over their data, and good outcomes.
PM Focus: Prioritize accessibility, plain language, and respect for autonomy. Never forget you're building for people who may be scared or vulnerable.
Providers (Clinicians)
Doctors, nurses, and other clinical staff. They want: efficient workflows, clinical accuracy, reduced administrative burden, and tools that help them provide better care.
PM Focus: Respect their expertise and time. Shadow them to understand real workflows. Reduce clicks and cognitive load—they have patients waiting.
Payers (Insurance)
Insurance companies and government programs. They want: cost reduction, quality metrics, compliance, and administrative efficiency.
PM Focus: Understand reimbursement models and value-based care. Show ROI through outcomes data. Help them meet quality requirements.
Health Systems
Hospitals and health networks. They want: operational efficiency, cost control, quality scores, interoperability, and security.
PM Focus: Enterprise sales skills matter. Integrate with existing systems (especially Epic/Cerner). Address IT security concerns proactively.
Regulators
FDA, OCR (HIPAA enforcement), state agencies. They want: patient safety, data protection, and compliance with applicable laws.
PM Focus: Build compliance into your DNA. Document everything. Engage regulatory counsel early. View regulations as features that enable trust.
Essential Skills for HealthTech PMs
Healthcare Domain Knowledge
- • Understand clinical workflows and terminology
- • Know how healthcare payment works
- • Grasp the patient journey across settings
- • Stay current on healthcare policy changes
Regulatory Fluency
- • Master HIPAA privacy and security rules
- • Understand FDA device classification
- • Know when clinical trials are needed
- • Partner effectively with compliance teams
Clinical Empathy
- • Shadow clinicians to understand their reality
- • Appreciate the stress of patient care
- • Design for users who are sick or scared
- • Build for accessibility and health literacy
Evidence-Based Thinking
- • Understand clinical validation requirements
- • Read and interpret clinical studies
- • Know when evidence is sufficient
- • Balance innovation with proven approaches
HealthTech PM Best Practices
Do This
- +Shadow clinicians in their actual environment
- +Build a clinical advisory board
- +Design for the stressed, scared, and unwell
- +Validate clinical claims with evidence
- +Plan for EHR integration early
Avoid This
- -Making unvalidated clinical claims
- -Treating HIPAA as an afterthought
- -Designing without clinical input
- -Ignoring health literacy levels
- -Prioritizing speed over patient safety
Frequently Asked Questions
What makes HealthTech PM different from other PM roles?
Key differences: (1) Life-or-death stakes—errors can harm patients, (2) Heavy regulation—HIPAA, FDA, GDPR for health data, (3) Complex stakeholders—patients, providers, payers, administrators all have different needs, (4) Long validation cycles—clinical validation and regulatory approval take time, (5) Integration challenges—must work with legacy EHR systems.
Do I need a clinical background for HealthTech PM?
Not required, but healthcare domain knowledge helps significantly. You should understand how healthcare delivery works: patient journeys, clinical workflows, payer models, and the regulatory landscape. Many successful HealthTech PMs come from non-clinical backgrounds and learn through exposure, mentorship, and deliberate study.
What is HIPAA and how does it affect product development?
HIPAA (Health Insurance Portability and Accountability Act) protects patient health information. Key requirements: (1) Only collect PHI you need, (2) Encrypt data at rest and in transit, (3) Implement access controls and audit logging, (4) Sign BAAs with vendors who handle PHI, (5) Train employees on privacy practices. Violations can result in massive fines.
How do I work with clinical teams?
Effective collaboration: (1) Learn clinical vocabulary—don't make them translate everything, (2) Shadow clinicians to understand their actual workflows, (3) Respect their time—they have patients to see, (4) Involve them early in design, not just validation, (5) Be humble—they know patient care better than you. Clinical advisory boards are invaluable.
What metrics matter in HealthTech?
Beyond typical metrics, HealthTech focuses on: (1) Clinical outcomes—did health improve? (2) Patient engagement—are patients using the product? (3) Provider adoption—do clinicians actually use it? (4) Compliance metrics—HIPAA adherence, adverse event reporting, (5) Time saved—clinical efficiency gains. Balance business metrics with health outcomes.
When does a product need FDA approval?
FDA regulates medical devices that diagnose, treat, or prevent disease. Software may be regulated if it: (1) Controls a medical device, (2) Provides clinical decision support that clinicians can't independently verify, (3) Diagnoses conditions, (4) Recommends treatments. Wellness apps are generally exempt. Work with regulatory counsel early—misclassification is expensive.
How do I balance innovation with patient safety?
Patient safety is non-negotiable, but it doesn't preclude innovation. Strategies: (1) Start with lower-risk applications and prove safety, (2) Build in human oversight for high-risk decisions, (3) Validate thoroughly before scaling, (4) Create clear escalation paths, (5) Monitor for adverse events post-launch. Move fast on UX, slow on clinical decisions.
What HealthTech sub-sectors can I specialize in?
Major HealthTech verticals: (1) Telehealth and virtual care, (2) Electronic Health Records (EHR), (3) Digital therapeutics, (4) Medical devices and wearables, (5) Healthcare administration/billing, (6) Clinical decision support, (7) Patient engagement platforms, (8) Healthcare AI/diagnostics. Each has unique regulatory and clinical requirements.
About the Author
Aditi Chaturvedi
·Founder, Best PM JobsAditi is the founder of Best PM Jobs, helping product managers find their dream roles at top tech companies. With experience in product management and recruiting, she creates resources to help PMs level up their careers.