Healthtech Startup Pack

What's inside

1. Prompt
   Healthtech Regulatory Classification — Is the Software a Medical Device? Questions for Regulatory Experts

   Organises whether a health app or software may be regulated as a medical device — intended purpose and claims, functions that may qualify, likely classification questions under EU MDR, UK and US FDA frameworks, how marketing claims change classification, and the evidence and questions to bring to regulatory experts.

2. Prompt
   Health Data Privacy Plan — HIPAA, GDPR Special Category Data and Business Associate Questions

   Prepares a healthtech startup to handle health data lawfully — mapping data flows, whether HIPAA applies and when business associate agreements are needed in the US, GDPR special category data conditions in Europe, consent, security controls, vendors and breach response — as questions and a plan for counsel and security leads.

3. Prompt
   Healthtech Clinical Evidence and Validation Study Plan

   Plans the evidence a health product needs to win clinicians, buyers and regulators — the claims to prove, evidence types from usability to real-world outcomes, study design options, ethics approvals, partner sites, data analysis and publishing results honestly.

4. Prompt
   Selling Digital Health to Clinics and Health Systems — Stakeholders, Pilots, Procurement and Integration

   Plans selling a digital health product to clinics, hospitals or health systems — mapping clinical, operational, IT, information governance and procurement stakeholders, value cases for each, pilots with clinical champions, integration and workflow fit, procurement frameworks and long sales cycles.

5. Prompt
   Health App Marketing Claims, App Store Listings and Advertising Rules

   Reviews health app marketing — claims consistent with the regulatory position, evidence behind outcomes, testimonials, app store health app guidelines, advertising platform health policies, and data use disclosures — with compliant rewrites.

6. Prompt
   Healthtech Clinical Safety Risk Management and Incident Process

   Sets up clinical safety management for a digital health product — hazard identification, risk analysis and controls, a safety case or risk file appropriate to the market, a clinical safety officer role where required, incident reporting and investigation, and safety review of product changes.

7. Skill
   Healthtech Startup Regulatory and Go-to-Market Partner

   A standing partner for healthtech founders: device classification questions, health data privacy, clinical evidence, selling to health systems, marketing claims and clinical safety — patient safety first, experts in the loop, claims matched to evidence.

From the wider PromptCorrectly library, picked for the same work. They come in the same .zip and the start file tells your AI when to use each one.

1. Skill
   Privacy Policy And GDPR Compliance Drafter

   Drafts and audits privacy policies against GDPR, CCPA/CPRA, and 2026 data-protection expectations.

   Library · In a pack
2. Prompt
   Plain-Language Summary for a Lay Audience

   Translates a technical study into an accurate plain-language summary for funders, patients, or the public without distortion.

   Library · In a pack
3. Prompt
   Privacy Policy Generator With Disclosure Map

   Drafts a privacy policy from a data-practices intake and maps each disclosure to the practice that requires it.

   Library · In a pack
4. Prompt
   Patient Intake — SOAP Note

   Compress a 20-min intake call into a structured clinical note a physician can scan in 60s.

   Library · Free
5. Prompt
   Two-Sided Contract Risk Review

   Reviews a contract from both parties' perspectives, scoring each material risk and proposing balanced fallback language.

   Library · In a pack
6. Prompt
   Stakeholder Alignment And Pre-Mortem Memo

   Surfaces stakeholder positions, maps a RACI, and runs a pre-mortem to expose failure modes before a major launch.

   Library · In a pack

A look inside

ROLE: You are a healthtech regulatory coordinator who prepares startups for conversations with regulatory consultants and notified bodies. Whether software is a medical device depends largely on its intended purpose and claims, and getting it wrong delays launches or creates legal risk, so you gather facts and questions precisely without making the determination yourself.

CONTEXT: The product, its functions …

Questions