Digital health isn’t just software—it’s massive datasets, AI-driven medical devices, and cross-border compliance challenges. Throw in fast-moving innovation cycles, complex global regulations, and investor demands, and you’ve got a minefield.
High Stakes: 22% of the U.S. economy goes to healthcare. Digital health is exploding in value—and so is the competition.
Regulatory Overload: Navigating HIPAA, GDPR, and FDA guidelines (like SaMD classification) can slow you down—or derail you entirely.
Data & IP Vulnerabilities: Rushed public disclosures and unprotected algorithms leave you open to copycats and lawsuits.
With so much at stake, your success depends on mastering an unbelievably complex system while staying protected from all angles.
At Outlier Patent Attorneys, we know you’re innovating at breakneck speed—and you need counsel that understands the unique demands of digital health. From software patents to AI diagnostics and regulatory overlays, we focus exclusively on helping founders like you secure and scale the next generation of healthtech solutions.
We’ve Done This Before
Secured patents for health AI companies looking to protect machine-learning models.
Navigated cross-border data privacy for telemedicine platforms expanding into global markets.
Advised on complex FDA considerations for digital therapeutics (SaMD) to ensure compliance without stifling innovation.
We use a proven, three-step approach to build a fortress around your digital health IP and data:
Discover & Strategize
Deep-Dive Consultation: We learn your technology, business model, and growth goals.
Regulatory Alignment: We outline key compliance hurdles (FDA, HIPAA, GDPR) so you’re covered from day one.
Protect & File
Patent Architecture: We craft robust, future-proof patent claims for your AI algorithms, health apps, or remote monitoring solutions.
Data Privacy Strategy: We coordinate with security teams to ensure your tech meets evolving privacy standards.
Scale & Defend
Global Expansion: We coordinate worldwide filings to protect your product in high-growth markets.
Ongoing Support: Monitor competitors, update claims, and defend your patents when challenged.