Healthcare Apps Built to Pass a Compliance Review

In engineering terms: encryption of protected health information in transit and at rest, access controls limiting each user to the minimum necessary data, an audit trail recording every access including reads, automatic session termination, secure backup and recovery, and business associate agreements with every vendor that touches PHI including your cloud provider. HIPAA is deliberately not prescriptive about technology, so it is about demonstrable controls and documentation rather than a specific product checklist.

Yes. Modern integration is normally FHIR R4 over an EHR vendor's API programme, which for Epic and Cerner means registering your application and going through their app-approval process — a timeline factor worth planning for early. Older interfaces use HL7 v2 messaging over an interface engine such as Mirth or Rhapsody. We work with both, and we build message validation and error queues rather than assuming clean feeds, because clinical data in the real world is not clean.

Fourteen to twenty-four weeks for a first production release, longer than a comparable consumer app. The extra time goes into compliance architecture, EHR integration work that depends on a third party's test environment and approval cycle, and clinical validation with real users. The compliance work is largely front-loaded, so a second product on the same platform moves considerably faster.

It depends on what the app claims to do, and this is a question for regulatory counsel rather than a development firm. Broadly, apps that support wellness, administration or communication generally fall outside device regulation, while software that diagnoses, recommends treatment or drives a clinical decision may be regulated as software as a medical device. We build to a documented development process that supports a regulatory submission where one is needed, and we will flag early when your intended claims look likely to cross that line.

Yes, before any access to production data or PHI. We also maintain BAAs with the infrastructure providers we deploy on, and where possible we deploy entirely inside your own cloud accounts so PHI never resides on our infrastructure. Our delivery process is ISO 27001:2013 certified, and we routinely complete hospital and payer vendor security assessments.

Yes, including our own eMS hospital management platform covering patient records, scheduling and billing, alongside client work in telemedicine, remote monitoring and patient engagement. Building and operating our own product matters here: we carry the consequences of our compliance and architecture decisions rather than handing them over at launch.