MedRecPro Terms of Service

A.1 Core Terms

These are the foundational terms used throughout this agreement:

Account

Your registered user account on MedRecPro, which represents your legal relationship with us and provides access to the Service.

Agreement

Refers collectively to these Terms of Service, our Privacy Policy, and all other operating rules, policies, and procedures published on MedRecPro.

Content

All materials available through the Service, including text, data, articles, images, software, SPL documents, and other materials, whether provided by MedRecPro or Users.

MedRecPro, We, Us

Refers to MedRecPro, the pharmaceutical labeling management platform, and its operators.

Service

The applications, software, products, and services provided by MedRecPro, including the web application, API, and any related tools or features.

User, You, Your

The individual, company, or organization that has registered for an Account, accesses the Service, or uses any part of the Service.

User Content

Content that you create, upload, or submit to the Service, including SPL documents, annotations, notes, and other materials.

A.2 Pharmaceutical Terms

Terms specific to pharmaceutical labeling:

SPL (Structured Product Labeling)

The FDA's standard for submitting product labeling content in XML format, as defined by HL7 specifications.

HL7

Health Level Seven International, the organization that develops standards for healthcare data exchange, including SPL specifications.

FDA

The United States Food and Drug Administration, the regulatory body responsible for pharmaceutical product labeling requirements.

21 CFR Part 11

FDA regulations establishing criteria for electronic records and electronic signatures.

B.1 Account Registration

You must register for an Account to access most features of the Service. Registration requires:

Authentication

You must authenticate using a supported provider (Microsoft, Google, or Apple). We do not store passwords directly.

Accurate Information

You must provide accurate and complete information during registration and keep your account information current.

Professional Use

MedRecPro is designed for professional use by pharmaceutical, healthcare, and regulatory professionals.

B.2 Account Requirements

The following requirements apply to all Accounts:

Age Requirement

You must be at least 18 years old to create an Account. MedRecPro is a professional tool not intended for minors.

One Account Per Person

Each individual may maintain only one personal Account. Organizations may have multiple user accounts under an organization subscription.

Human Users

Accounts must be registered by humans. Automated account creation is not permitted without prior written authorization.

Legal Compliance

You may not use MedRecPro in violation of applicable laws, including export control or sanctions laws of the United States.

B.3 Account Security

You are responsible for maintaining the security of your Account:

Security Responsibility

You are responsible for all activity that occurs under your Account, including actions taken by others with access to your Account.

Unauthorized Access

You must notify us immediately at [email protected] if you become aware of any unauthorized access to or use of your Account.

Authentication Provider Security

Your Account security depends in part on your authentication provider. Ensure your Microsoft, Google, or Apple account is properly secured.

B.4 Organization Accounts

If you access MedRecPro through an organization account provided by your employer or institution, additional terms may apply as specified in your organization's agreement with us. Your organization's administrator may have control over your account and access to your data.

C.1 Lawful Use

You agree to use the Service only for lawful purposes and in compliance with:

Applicable Laws

All applicable federal, state, local, and international laws and regulations.

FDA Regulations

FDA regulations regarding pharmaceutical labeling, including 21 CFR Part 201 and related requirements.

Export Controls

U.S. export control and sanctions laws. You may not use the Service if you are subject to U.S. sanctions or export restrictions.

C.2 Prohibited Activities

You may not engage in the following activities:

Unauthorized Access

Attempting to access accounts, systems, or data without authorization, or bypassing security measures.

Service Disruption

Interfering with or disrupting the Service, servers, or networks connected to the Service.

Malicious Code

Uploading or transmitting viruses, malware, or other malicious code.

Scraping and Harvesting

Using automated means to scrape, harvest, or extract data from the Service without authorization.

Impersonation

Impersonating another person or entity, or falsely claiming affiliation with any person or entity.

Fraudulent Submissions

Using the Service to create or process fraudulent or intentionally misleading pharmaceutical labeling documents.

C.3 Rate Limits and Fair Use

To ensure service availability for all users, we may implement rate limits on API requests and certain features. Excessive or abusive use that impacts service performance for other users is prohibited.

D.1 Ownership of User Content

You retain all ownership rights to User Content you upload, create, or submit to the Service. MedRecPro does not claim ownership of your SPL documents, annotations, or other User Content.

D.2 License Grant to MedRecPro

By uploading User Content to the Service, you grant MedRecPro a limited license to:

Service Operation

Store, process, display, and transmit your User Content as necessary to provide the Service.

Technical Processing

Parse, validate, render, and transform SPL documents according to FDA and HL7 specifications.

Backup and Recovery

Create backup copies of your User Content for data protection and disaster recovery purposes.

D.3 Responsibility for User Content

You are solely responsible for:

Content Accuracy

The accuracy, completeness, and regulatory compliance of all User Content, including SPL documents.

Rights to Content

Ensuring you have all necessary rights, licenses, and permissions to upload and use the User Content.

Regulatory Submissions

Reviewing and verifying all content before submission to regulatory authorities. MedRecPro is a tool to assist your workflow, not a substitute for professional judgment.

Confidential Information

Appropriately handling any confidential, proprietary, or trade secret information in your User Content.

D.4 Content Removal

We reserve the right to remove User Content that violates these Terms, applicable law, or poses security risks. We will attempt to notify you before removing content except where prohibited by law or in emergency situations.

D.5 No Protected Health Information

MedRecPro is not designed to store or process Protected Health Information (PHI) as defined by HIPAA. Do not upload patient-identifiable health information to the Service. If you inadvertently upload PHI, notify us immediately at [email protected].

E.1 Open Source License

The MedRecPro software is provided under the Apache License, Version 2.0. You may obtain a copy of the License at https://www.apache.org/licenses/LICENSE-2.0. Subject to the terms of the Apache 2.0 License, you are free to use, modify, and distribute the software.

E.2 Source Code

The source code for MedRecPro is available on GitHub. Contributions to the project are welcome under the terms of the Apache 2.0 License and our Contributor License Agreement.

E.3 Trademarks

The MedRecPro name, logo, and other branding are trademarks of MedRecPro. The Apache 2.0 License does not grant rights to use these trademarks. You may not use our trademarks in a way that suggests endorsement or affiliation without prior written permission.

E.4 Third-Party Components

MedRecPro incorporates third-party open-source components, each subject to its own license terms. A list of third-party components and their licenses is available in the project repository.

E.5 Feedback

If you provide feedback, suggestions, or ideas about the Service ('Feedback'), you grant MedRecPro a non-exclusive, royalty-free, perpetual, irrevocable license to use, modify, and incorporate the Feedback into the Service without obligation to you.

F.1 AI Service Providers

AI-powered features are provided through third-party AI services, including Anthropic's Claude API. Your use of AI features is subject to both these Terms and the applicable third-party terms of service.

F.2 Data Processing for AI Features

When you use AI-powered features, relevant portions of your queries and document content may be sent to AI service providers for processing. We do not use your content to train AI models. See our Privacy Policy for details on data processing.

F.3 AI Output Limitations

AI-generated analysis and suggestions are provided for informational purposes only:

Not Professional Advice

AI outputs do not constitute regulatory, legal, medical, or professional advice.

Verification Required

You must independently verify all AI-generated content before relying on it for regulatory submissions or business decisions.

No Warranty

We make no warranties regarding the accuracy, completeness, or suitability of AI-generated content.

F.4 AI Feature Availability

AI features may be modified, limited, or discontinued at any time. Availability may vary based on your subscription tier and usage limits.

G.1 User Responsibility

You are solely responsible for ensuring your use of MedRecPro complies with all applicable regulatory requirements, including:

FDA Requirements

FDA regulations for pharmaceutical labeling, including 21 CFR Part 201, SPL submission requirements, and related guidance documents.

21 CFR Part 11

If your use of MedRecPro is subject to 21 CFR Part 11 requirements for electronic records and signatures, you are responsible for implementing appropriate controls.

International Regulations

Applicable pharmaceutical labeling regulations in other jurisdictions where your products are marketed.

Industry Standards

HL7 SPL Implementation Guide specifications and other applicable industry standards.

G.2 Tool Limitations

MedRecPro is a tool to assist pharmaceutical labeling workflows. It is not a validated system under 21 CFR Part 11 and does not replace your organization's quality management systems, validation procedures, or regulatory compliance programs.

G.3 No Regulatory Advice

MedRecPro does not provide regulatory advice. Information displayed in the Service regarding FDA requirements or SPL specifications is for reference only. Consult with qualified regulatory professionals for compliance guidance.

G.4 Audit Trail

MedRecPro maintains activity logs for security and operational purposes. If you require specific audit trail capabilities for regulatory compliance, you are responsible for verifying that MedRecPro's logging meets your requirements.

H.1 Free Tier

MedRecPro provides a free tier with basic functionality. Free tier features and limitations are described on our website and may change over time.

H.2 Paid Subscriptions

Paid subscription tiers provide access to additional features, higher usage limits, and priority support. Current pricing is available at https://medrecpro.com/pricing.

H.3 Billing

For paid subscriptions:

Billing Cycle

Subscriptions are billed in advance on a monthly or annual basis as selected during signup.

Payment Methods

We accept payment via credit card and other methods as displayed during checkout.

Price Changes

Subscription prices may change. We will provide at least 30 days' notice of price increases, and changes will apply at your next billing cycle.

Taxes

Prices do not include applicable taxes. You are responsible for all taxes associated with your subscription.

H.4 Refunds

Subscription fees are generally non-refundable. We may, at our discretion, provide refunds or credits in cases of billing errors or service issues.

I.1 Account Cancellation by You

You may cancel your Account at any time through your account settings or by contacting [email protected]. Upon cancellation, your right to access the Service terminates immediately.

I.2 Data Upon Cancellation

Upon Account cancellation:

Data Export

You may export your User Content before cancellation. We recommend downloading all data you wish to retain.

Data Deletion

We will delete your User Content within 90 days of cancellation, except where retention is required for legal obligations.

Backup Retention

Deleted content may persist in encrypted backups for up to 30 additional days.

I.3 Termination by MedRecPro

We may suspend or terminate your Account if you violate these Terms, engage in prohibited activities, or for other reasons with notice. In cases of severe violations, we may terminate immediately without notice.

I.4 Effect of Termination

Upon termination, your right to use the Service ceases. Provisions of these Terms that by their nature should survive termination will survive, including ownership provisions, warranty disclaimers, and limitations of liability.

J.1 No Warranties

TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, MEDRECPRO DISCLAIMS ALL WARRANTIES, WHETHER EXPRESS, IMPLIED, OR STATUTORY, INCLUDING WITHOUT LIMITATION:

Merchantability

Any warranty of merchantability or fitness for a particular purpose.

Accuracy

Any warranty that the Service will be accurate, reliable, error-free, or uninterrupted.

Regulatory Compliance

Any warranty that the Service will meet your regulatory compliance requirements.

Security

Any warranty that the Service will be secure or free from vulnerabilities.

Third-Party Services

Any warranty regarding third-party services integrated with MedRecPro.

J.2 Open Source Disclaimer

As open-source software provided under the Apache 2.0 License, MedRecPro is provided WITHOUT WARRANTIES OR CONDITIONS OF ANY KIND, either express or implied, including without limitation any warranties or conditions of TITLE, NON-INFRINGEMENT, MERCHANTABILITY, or FITNESS FOR A PARTICULAR PURPOSE.

J.3 Professional Judgment

MedRecPro is a tool to assist your work. It does not replace professional judgment, regulatory expertise, or compliance programs. You assume full responsibility for decisions made based on Service outputs.

K.1 Exclusion of Damages

TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, IN NO EVENT SHALL MEDRECPRO BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES, INCLUDING WITHOUT LIMITATION:

Loss of Profits

Loss of profits, revenue, business opportunities, or goodwill.

Data Loss

Loss of data, including User Content or SPL documents.

Service Interruption

Costs arising from service interruption or inability to use the Service.

Third-Party Claims

Claims by third parties arising from your use of the Service.

Regulatory Actions

Regulatory enforcement actions, fines, or penalties related to your use of the Service.

K.2 Liability Cap

TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, MEDRECPRO'S TOTAL LIABILITY ARISING OUT OF OR RELATED TO THESE TERMS OR YOUR USE OF THE SERVICE SHALL NOT EXCEED THE GREATER OF (A) THE AMOUNTS PAID BY YOU TO MEDRECPRO IN THE TWELVE (12) MONTHS PRECEDING THE CLAIM, OR (B) ONE HUNDRED DOLLARS ($100).

K.3 Basis of the Bargain

The limitations and exclusions in this section apply regardless of the theory of liability and even if MedRecPro has been advised of the possibility of such damages. These limitations are an essential basis of the bargain between you and MedRecPro.

K.4 State Law Variations

Some jurisdictions do not allow the exclusion of certain warranties or limitation of liability. In such jurisdictions, our liability shall be limited to the maximum extent permitted by law.

L.1 Indemnified Claims

Your indemnification obligation covers:

Terms Violation

Your violation of these Terms or any applicable law or regulation.

User Content

Your User Content, including any claims that your content infringes third-party rights.

Regulatory Non-Compliance

Your failure to comply with applicable regulatory requirements in your use of the Service.

Third-Party Disputes

Disputes between you and third parties related to your use of the Service.

L.2 Defense Cooperation

We will provide reasonable cooperation in the defense of any claim and you will not settle any claim without our prior written consent if the settlement would impose obligations on us or admit liability on our behalf.

M.1 Electronic Communications

You consent to receive communications from us electronically via the email address associated with your Account or through the Service. You agree that electronic communications satisfy any legal requirement for written communications.

M.2 Service Notifications

We may send you notifications about your Account, service changes, security alerts, and other matters related to the Service. You may not opt out of critical service and security notifications.

M.3 Support Communications

MedRecPro provides support via email and in-Service communications. We do not currently offer telephone support. Contact us at [email protected] for assistance.

N.1 Right to Modify

We reserve the right to modify these Terms at any time. We will update the 'Last Updated' date at the top of these Terms when we make changes.

N.2 Notice of Material Changes

For material changes, we will provide at least 30 days' notice before the changes take effect. Notice may be provided via email to your registered email address or through a prominent notice on the Service.

N.3 Acceptance of Changes

Your continued use of the Service after the effective date of revised Terms constitutes your acceptance of the changes. If you do not agree to the revised Terms, you must stop using the Service and cancel your Account.

N.4 Version History

Previous versions of these Terms may be available upon request for reference purposes.

O.1 Governing Law

These Terms and any dispute arising out of or related to these Terms or the Service shall be governed by and construed in accordance with the laws of the United States of America and the State of Maryland, without regard to conflict of law principles.

O.2 Jurisdiction and Venue

You agree to submit to the exclusive jurisdiction of the state and federal courts located in the State of Maryland for any dispute arising out of or related to these Terms or the Service. You waive any objection to venue in such courts.

O.3 Informal Resolution

Before initiating any formal dispute resolution, you agree to first contact us at [email protected] to attempt to resolve the dispute informally. We will attempt to resolve disputes within 30 days of receiving notice.

O.4 Class Action Waiver

TO THE EXTENT PERMITTED BY APPLICABLE LAW, YOU AND MEDRECPRO AGREE THAT EACH MAY BRING CLAIMS AGAINST THE OTHER ONLY IN YOUR OR OUR INDIVIDUAL CAPACITY AND NOT AS A PLAINTIFF OR CLASS MEMBER IN ANY PURPORTED CLASS OR REPRESENTATIVE ACTION.

P.1 Entire Agreement

These Terms, together with the Privacy Policy and any other agreements expressly incorporated by reference, constitute the entire agreement between you and MedRecPro regarding the Service and supersede all prior agreements and understandings.

P.2 Severability

If any provision of these Terms is held to be invalid or unenforceable, that provision shall be modified to the minimum extent necessary to make it enforceable, or if modification is not possible, severed from these Terms. The remaining provisions shall continue in full force and effect.

P.3 Waiver

Our failure to enforce any provision of these Terms shall not constitute a waiver of that provision or our right to enforce it in the future.

P.4 Assignment

You may not assign or transfer these Terms or your rights under these Terms without our prior written consent. We may assign these Terms without restriction in connection with a merger, acquisition, or sale of assets.

P.5 Force Majeure

MedRecPro shall not be liable for any failure or delay in performance due to causes beyond our reasonable control, including natural disasters, war, terrorism, strikes, government actions, or internet service provider failures.

P.6 Headings

Section headings are for convenience only and do not affect the interpretation of these Terms.

P.7 Survival

Provisions that by their nature should survive termination shall survive, including without limitation: ownership provisions, warranty disclaimers, indemnification, limitations of liability, and dispute resolution provisions.