| Telemedicine and Virtual Care | Doctors, clinics, hospitals, remote patients | - HIPAA
- GDPR
- State licensure rules and interstate compacts
- State telehealth informed-consent laws
- DEA telemedicine prescribing rules
| - Video conferencing
- EHR/EMR systems
- E-prescribing services
- Payment systems
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| Patient Engagement and Patient Portals | Patients, hospitals, clinics, care teams | - HIPAA and GDPR
- Accessibility requirements, such as WCAG 2.1 AA
| - EHR/EMR systems
- Appointment scheduling
- Laboratory systems
- Patient-record systems
|
| Mobile EHR and Clinician Productivity | Physicians, nurses, other clinical staff | - HIPAA/HITECH
- GDPR
- HIPAA Security Rule technical safeguards
| - EHR platforms: Epic, Oracle Health, athenahealth
- SMART on FHIR
- HL7 v2 interfaces
- Secure messaging
- E-prescribing
- Imaging viewers (PACS)
|
| Mental Health and Behavioral Health | Therapists, psychiatrists, counselors, patients | - HIPAA
- GDPR
- 42 CFR Part 2 for qualifying substance-use-disorder records
| - Video conferencing
- EHR/EMR systems
- E-prescribing
- Billing or payment systems
|
| Chronic Disease and Care Management | Patients, physicians, care coordinators, other healthcare providers | - HIPAA
- GDPR
- FDA oversight and EU MDR requirements may apply when an app qualifies as SaMD
- FTC Health Breach Notification Rule
| - Wearables
- Bluetooth-enabled medical devices
- Apple HealthKit
- Health Connect (Android)
- EHR/EMR systems
|
| Wellness, Fitness and Preventive Care | Individuals, wellness providers, fitness businesses, insurers | - FTC Act
- GDPR and consumer privacy laws
- HIPAA for covered-entity or business-associate activities
| - Apple HealthKit
- Health Connect (Android)
- Fitness trackers
- Wearable devices
|
| Pharmacy, e-Prescribing and Laboratory Apps | Pharmacists, laboratory staff, physicians, patients | - HIPAA
- GDPR
- DEA EPCS rules (21 CFR Part 1311)
- CMS EPCS program
- NCPDP SCRIPT standard
- State EPCS and PDMP requirements
- CLIA requirements
| - EHR/EMR systems
- Laboratory information systems
- Pharmacy management systems
- E-prescribing networks
- PDMP systems
- PBMs and payers
|