Digital Health

What is Digital Health?

Definitions, frameworks, and the FDA landscape​

DHTs Patient-Facing

Health & Wellness: General wellness, no disease claim

Patient Monitoring: RPM, CGMs, cardiac monitors

Care support: education, reminders

Digital diagnostics: detect or measure disease

Digital therapeutics: Software-delivered treatment (DTx)

Health & Wellness

General wellness, no disease claim

Patient Monitoring

RPM, CGMs, cardiac monitors

Care support

education, reminders

Digital diagnostics

detect or measure disease

Digital therapeutics

Software-delivered treatment (DTx)

DHTs Admin-Facing

Non-health system software: Pharma, payers, employers

Health system operational: admin & financial HIT

Health system clinical: Clinician- facing tools

FDA classification Health & Wellness + example

Regulatory Scrutiny: None

Evidence Bar: Not Required

Ex: Step tracker, sleep app

FDA classification Patient Monitoring (RPM) + example

Regulatory Scrutiny: Moderate - FDA clearance for many devices

Evidence Bar: Clinical validation

Ex: CGM, BP cuff, pulse ox

FDA classification Care support + example

Regulatory Scrutiny: Low-moderate

Evidence Bar: Some evidence preferred

Ex: Diabetes education app

FDA classification Digital Diagnostics + example

Regulatory Scrutiny: High - FDA cleared/authorized

Evidence Bar: Clinical validation required

Ex: ECG app (Apple watch)

FDA classification Digital Therapeutics (DTx) + example

Regulatory Scrutiny:

Evidence Bar:

Ex:

Digital Therapeutics (DTx)

Software as a standalone treatment intervention​

1. Evidence-based: supported by RCT-level clinical data

2. Software IS the TX: software delivers the intervention; NOT companion app

3. Regulatory Oversight: FDA, cleared/authorized/approved

4. Clinical claims: Treats, manages, or prevents a diagnosed condition

5. Measurable outcomes: Patient-relevant endpoints validated in trials

DTx in Practice

EndeavorRX

EndeavorOTC

EndeavorRx

FDA-AUTHORIZED

▸ First FDA-authorized prescription digital therapeutic (PDT)​

▸ Indicated for children ages 8–12 with primarily inattentive orcombined-type ADHD​

▸ Delivered as a video game — improves attention throughadaptive cognitive challenges​

▸ Requires a prescription — new treatment category alongside(not replacing) medication​

▸ Coverage: increasingly included in benefit designs

EndeavorOTC

NOT FDA CLEARED

▸ Adult OTC version (18+) made by Akili Interactive​

▸ Marketed to improve attention function and quality of life inadults with ADHD​

▸ Available without a prescription; FSA/HSA eligible​

▸ Operates under FDA enforcement discretion — NOT formallycleared or authorized​

▸ Label literacy: 'FDA-authorized technology' ≠ the product itself isFDA-authorized

Remote Patient Monitoring (RPM)

Closing the gap between clinic visits

RPM: How it works

1. Patient collects data: CGM, BP cuff, pulse ox, weight scale

2. Device transmits: Bluetooth, cellular, or Wi-Fi to platform

3. Data reviewed by care team: Pharmacist, NP, or physician reviews trends

4. Intervention & follow-up: Medication adjustment, counseling, escalation

The Pharmacist's Role in RPM​

• Review transmitted data

• identify trends and outliers

• Counsel on proper device use, calibration, and timing

• Communicate actionable findings to the prescriber

• Help patients understand what their data means and what it doesn’t

RPM examples

Blood glucose monitors/CGMs, bluetooth blood pressure cuffs, pulse oximeters, connected weight scales, cardiac monitors/ECG apps, smart inhalers

How digital therapeutics & RPM bridge the gap

• Treatment without geographic limits

• Pharmacy-led telehealth & RPM programs

• RPM replaces routine office visits

• Critical equity consideration

How to Evaluate a Digital Health Tool: Counseling Framework​

1. What does this tool claim to do?

2. Is it FDA cleared or authorized

3. What’s the evidence?

4. What data does it collect?

5. Is the patient able and likely to use it?

How to counsel elderly patients

May not own smartphones or know how to use apps​ → Offer to help set up iPhone Medical ID — 5 minutes,potentially lifesaving​

How to counsel Rural/Desert Communities

No broadband, no pharmacy, provider shortage​ → RPM and DTx can reach them — but assess connectivity first.Know telehealth resources.​

How to counsel Digital Literacy Gaps​

Cannot navigate apps, devices, or portals effectively​ → Assess before recommending. Simplify instructions. Loop incaregivers.​

How to counsel Non-English Speakers​

AI and apps often English-only; algorithmic bias in training data​ → Language access is a patient safety issue. Flag apps withoutlanguage support.​

How to counsel Uninsured / Underinsured​

DTx and RPM may require devices, data plans, or co-pays​ → Know which tools are FSA/HSA eligible or covered byMedicaid/Medicare Advantage.​

Pharmacist role in digital health

The pharmacist's role is to meet patients where they are; not where technology assumes them to be.​

What AI does well

▸ General health education and medicationoverviews​

▸ Summarizing complex conditions in plainlanguage​

▸ Accessible 24/7 - no appointment needed​

▸ Can prompt patients to seek professionalcare​

▸ Useful starting point for health literacy

Where AI Falls Short​

▸ Does NOT know patient's full history,allergies, or current meds​

▸ Answers in a vacuum, context-blind​

▸ Responses sound authoritative even whenwrong​

▸ Patients can't distinguish well-written wrongfrom correct​

▸ May amplify health misinformation at scale

The Pharmacist's Role in AI​

▸ Personalized, context-aware, accountableexpertise​

▸ Can reconcile AI output with patient's actualregimen​

▸ Clinical judgment AI cannot replicate​

▸ 'I can review what it told you and verify it'​

▸ Document AI-informed concerns in patientprofile

When a patient asks about an app

ask what it claims to do,then check Devices@FDA before offering an opinion on safety or accuracy.

If a patient says 'I looked it up on ChatGPT,'

respond with curiosity not dismissal. Offer to verify it against their specific situation.​

RPM data is only useful if someone reviews it

Ask who is monitoring the patient's readings — and offer to be that person if your setting allows.​

iPhone Medical ID setup

takes 5 minutes and could save your patient's life in an emergency — make this a standard counseling point.​

Before recommending any digital health tool, assess

Does the patient own a smartphone? Have internet access? Can they navigate the interface?​

For patients in pharmacy or medical deserts

digital therapeutics and pharmacist-led telehealth may be the most accessible care they can get.​