NO PURCHASE OR PAYMENT NECESSARY. A PURCHASE OR PAYMENT OF ANY KIND WILL NOT INCREASE YOUR CHANCES OF WINNING. VOID WHERE PROHIBITED 

Introduction 

The Breakthrough Alliance (“BTA”), a digital health research consortium, was created to accelerate a greater number of digital health innovations through the generation of exclusive, evidence-based research and insights. The BTA Research & Strategy Program (“Program”) provides research and testing to innovative technology companies worldwide as determined by the research consortium. The Call for Applications (“Call for Applications”) to the Program seeks to identify health related or healthcare technology companies (“Applicants” or “Innovators”) that may be best suited to implement a pilot project (“Pilot”) under certain criteria as explained below and may be determined by the Program leadership including Sponsor and Administrator. Each Pilot will be administered by HITLAB in a sample of appropriate target end users for a research study duration (sample size and duration shall be determined on a case-by-case basis to achieve valid, rapid verification efforts and at the sole discretion of BTA). Specific Program goals include: 

• Enable health or healthcare technology companies to benefit from rigorous and cost-effective methods for generating meaningful, evidence-driven data that seek to validate their concept, prototypes, or products and attract key clients and investors.
• Expand the network of stakeholders granted access to digital health resources
• Accelerate the growth and development of health/healthcare Innovator solutions worldwide.

1. Sponsor and Administrator 

The sponsor of the Program (the Sponsor”) is the consortium of entities responsible for the Breakthrough Alliance as described on the BTA website. The Administrator (as defined below) manages and implements the Call for Applications on behalf of the Sponsor. The “Administrator” is Healthcare Innovation and Technology Lab, Inc. (“HITLAB”), 3960 Broadway, Suite 310G, New York, NY 10032. The first generation of the BTA was originally launched by New York City Economic Development Corporation (“NYCEDC”) as the Digital Health Breakthrough Network (“DHBN”) in 2016 as part of its broader efforts to facilitate growth in New York City’s healthcare and life sciences sectors. Now, HITLAB operates the program independently and continues to provide prototype testing services to the digital health ecosystem. 

2. Overview of Call for Applications – Fall dates for 2024 

A Call for Applications to the Program will be administered by the Administrator. The number of calls and Pilot projects may be modified at any time at the sole discretion of the Administrator. 

July 26th, 2024: Call for Applications portal goes live. 

October 15th, 2024: Deadline for all Applications from all channels. 

October 19th-27th, 2024: Judging period begins. 

October 29th, 2024: Finalists shall be chosen and contacted for eligibility; and may be announced publicly thereafter. 

October 31st, 2024: Finalist publicly announced 

December 2nd, 2024: Finalist will present their digital health solutions at the HITLAB Innovators Summit, and 3 prize winners will be officially announced. 

*All deadlines are at 11:59 pm Eastern Time on the respective days, unless otherwise stated. 

3. Eligibility 

• This program is open only to Applicants who submit an application in accordance with the application requirements below and who meet the following criteria:
  • if an individual, an Applicants must be at least 18 years of age at the time of entry, are legal residents of countries where such challenges are allowed by the laws of those countries (excluding the residents of Russia, Cuba, Iran, Libya, North Korea, Sudan, and Syria), as of the time of entry and when winners are announced;
  • if a team of eligible individuals, the Applicant team must be composed of members who each meet the eligibility requirements for individual Contestants; or
  • if a corporation, limited liability company, partnership, or other legal entity, a Contestant must, at the time of entry:
    • Be legally formed, maintaining its primary place of business in the United States;
    • Have sufficient funding to continue operations for the next 12 months from any source;
    • Have a functional product prototype available for testing
• The following individuals, teams, and organizations are ineligible to participate as Applicants or Innovators (as defined below) regardless of whether or not they meet the criteria set forth above:
  • the Sponsor and all of its employees and representatives, and each of their family members and household members of the Sponsor’s employees and representatives;
  • the Administrator and all of its employees and representatives, and each of their family members and household members; 

For the purposes of clarification, ‘family members ’include such individual’s spouse, children, step-children, parents, step-parents, siblings and step-siblings. ‘Household members ’include any other person who shares the same residence as such individual for at least three (3) months out of the year. 

4. Application Requirements 

The Administrator reserves the right to update the application requirements for the Call for Applications at any time. All changes to the application requirements will be announced on the Call for Applications website. The full application requirements (initial and follow-up) along with all documents submitted shall be referenced as the “Submission.” Each Submission will require the following information: 

• Submission Form
  • Contact information
  • Company Name
  • Your Country
  • Link to Website/LinkedIn
  • Describe your digital health solution 
  • How do you categorize your product/solution? 
  • Select the stage of development that applies to your product or solution? [Select one]
  • How much funding have you raised to date?
  • How will you be able to raise and sustain funding?
  • Please describe your business plan and the feasibility of long-term product growth based on the current and future market.
  • Share any links relevant to your application. 
  • If you are selected, are you ready, willing, and able to provide the necessary research data and other relevant information necessary to participate in a research study of your digital health solution within 30 days (about 4 and a half weeks) of the final pitch day?
  • If not selected, are you interested in being contacted by HITLAB for research, advisory, and/or education services? 

5. Submission Rights and Display

All Submissions may be disclosed in accordance with the standards specified in the Freedom of Information Law, Article 6 of the Public Officers Law of the State of New York (“FOIL”). A respondent may provide in writing, at the time of its Submission, a detailed description of the specific information contained in its Submission which it has determined is a trade secret and which, if disclosed, would substantially harm such entity’s competitive position. This characterization shall not be determinative but will be considered by the Administrator when evaluating the applicability of any exemptions in response to a FOIL request. 

6. Selection of Winners / Judging Criteria 

• All Submission reviews will be conducted by a qualified panel of impartial judges (the “Judges”) selected by the Sponsor and/or Administrator. A review may be conducted in one or more rounds of judging, and each round of judging may involve different Judges. The Sponsor and/or the Administrator reserve the right to substitute or modify the judging panel or criteria at any time for any reason.  
• All Judges shall be and remain fair and impartial. Any Judge may recuse him or herself from judging if the Judge, the Sponsor and/or the Administrator considers that it is inappropriate, for any reason, for the Judge to evaluate a specific Submission or group of Submissions. This includes, but is not limited to, cases where a Judge has a material business relationship or affiliation with a Contestant.
• Judges will use the following four criteria for evaluation of each Submission:
  • Innovation: Includes innovativeness of the product and approach, the scale of the problem is seeking to address. 
  • Scalability: Includes market size and realism of market size estimations supported by established management  
  • Sustainability: Includes completeness and realism of business plan and feasibility of the core team in supporting long-term product growth based on the current and future market  
  • Impact: The digital health solution or product is demonstrated to have an impact on the target population based on extent of potential impact on critical health care needs, and extent of product testing previously performed and required  

7. Verification of Winners

The Administrator may request additional information and/or conduct interviews with potential winning Applicants to verify the application information submitted. The winning Applicants will be required to sign a contract detailing the terms of the pilot within 30 days of the announcement of the winners (such winning Applicant after signing, shall be deemed an “Innovator”). All winners must be prepared to provide the necessary research data and other relevant information within 30 days of their official eligibility.  Testing and evaluating digital medical research tools or applications often requires a diverse set of data to ensure their effectiveness, safety, and compliance with regulatory requirements. Here are some types of data that may be needed for testing and evaluating digital medical research tools or applications keeping in mind that the specific data required will depend on the nature and purpose of the digital medical research tool or application, as well as regulatory and ethical considerations.  Data privacy and security measures shall be in place to protect confidential information. However, under no circumstances shall any patient health information or sensitive patient information (as defined under health care laws) be provided or requested.  That research data and research criteria may include the following:  

Data may include: De-Identified Patient Data (i.e. diagnoses, treatment plans, and outcomes); Clinical Trial Data (i.e. patient demographics, treatment protocols, and outcomes); Genomic and Genetic Data (i.e. genetic sequencing data and genetic variations); Imaging Data (i.e. X-rays, MRI scans, and CT scans); Laboratory Data (i.e. experimental and lab-generated data, including assays, test results, and measurements); Biological Data Samples (for applications involving biomarker analysis or diagnostic testing); Real-World Data (i.e. data collected in real-world healthcare settings, such as electronic health records (EHRs) and claims data); Simulation Data (i.e. simulated patient data can be used for initial testing and development before real patient data is utilized); Quality Assurance Data (i.e. software testing results, bug reports, and user feedback); User Interaction Data (i.e. user behavior, preferences, and user interface feedback); Security and Privacy Data (i.e. cybersecurity, encryption, and privacy features); Regulatory Data (i.e. regulatory approvals, certifications, and compliance with healthcare standards and regulations, such as FDA submissions, if applicable; Clinical Guidelines and Protocols (i.e. clinical guidelines, best practices, and medical protocols); Population Data (i.e. demographic and epidemiological data); Device Data (i.e. data from medical devices, wearables, or sensors that interact with the solution); Cost and Economic Data (i.e. economic data may be required for cost-effectiveness analysis and health economics research if the tool impacts healthcare costs); User Training Data (i.e. data on training sessions and educational materials provided to users of the solution); Adverse Event Data (data on adverse events or side effects reported by users or patients when using the digital solution). 

8. Prizes 

Subject to the Applicant’s compliance and agreement with all the terms and conditions of the award, 

The chosen Innovators will receive eligibility to participate in a rapid pilot study designed and implemented by the Administrator and funded by the Sponsor (the “Prize”). The parameters of the in-kind services provided by HITLAB’s research and evaluation team in the form of a research study shall be subject to change at any time upon the sole discretion of the Sponsor and Administrator. No cash or monetary value will be directly awarded to Innovators. There will be 3 tiers of prize winners which shall all receive in-kind services (in the form of a research study) from our research and evaluation team in addition to a HITLAB feature. 3rd place will receive a research study and a symposia feature, 2nd place a research study, Symposia presentation, and article (publication), and 1st place a research study, article, and a presentation at a HITLAB symposia/summit in addition to a sub-cut social media video. All prizes must be used within 6 months of meeting eligibility requirements. 

• No Prize substitutions will be made. Prizes must be accepted as awarded. No transfer or substitution of a Prize is permitted except at the Administrator’s sole discretion. The Prize will be provided following receipt of (i) signed affidavit(s) of eligibility or such evidence as requested by the Administrator and (ii) any liability or publicity release(s) or form(s)
• Each Applicant hereby acknowledges and agrees that the relationship between the Applicant and the Administrator, is not a confidential, fiduciary, or any other relationship involving a duty of trust, a duty of loyalty, representation or agency, and that the Applicant’s decision to provide the Applicant’s Submission to the Administrator for the purposes of this Call for Applications does not place the Administrator, and their respective agents in a position that is any different from the position held by the general public regarding elements of the Submission, except as specifically provided in these Official Rules.

The Administrator reserves the right to (a) disqualify any Applicant and (b) withhold distribution of the Prize to any Innovators that violate any of these Official Rules. 

9. Entry Conditions and Release 

• By entering or participating in any part of the program, each Applicant (including all participating individuals comprising an Applicant) agree(s) to:
  • comply with and be bound by these Official Rules and the decisions of the Administrator and/or the BTA Board members which are binding and final in all matters relating to this Call for Applications;
  • release, indemnify, defend and hold harmless the Sponsor, the Administrator, and each of their respective parent, subsidiary, and affiliated companies, the Prize suppliers, the City of New York, and any other organizations responsible for sponsoring, fulfilling, administering, advertising or promoting the Call for Applications, and all of their respective past and present officers, directors, employees, agents and representatives (hereafter the “Released Parties”) from and against any and all claims, expenses, and liabilities (including reasonable attorneys ’fees), including but not limited to any negligence, defamation, slander, libel, violation of right of publicity, infringement of trademark, copyright or other intellectual property rights, property damage, or death or personal injury arising out of or relating to an Applicant’s Submission (including without limitation the broadcast, transmission, performance, exploitation or use of such Submission), an Applicant’s participation in the Call for Applications, the Prize (including, without limitation, any travel or activity related thereto), or an Applicant’s participation in a Pilot. 
• Without limiting the foregoing, the Released Parties shall have no liability in connection with:
  • any incorrect or inaccurate information, whether caused by the Administrator’s or an Applicant’s electronic or printing error or by any of the equipment or programming associated with or utilized in the Call for Applications;
  • technical failures of any kind, including, but not limited to malfunctions, interruptions, or disconnections in phone lines, internet connectivity or electronic transmission errors, or network hardware or software or failure of the Call for Applications website;
  • unauthorized human intervention in any part of the entry process or the Call for Applications;
  • technical or human error which may occur in the administration of the Call for Applications or the processing of Submissions; or
  • any injury or damage to persons or property which may be caused, directly or indirectly, in whole or in part, from the Applicant’s participation in the Call for Applications or receipt or use or misuse of any Prize. If for any reason any Applicant’s Submission is confirmed to have been erroneously deleted, lost, or otherwise destroyed or corrupted, the Applicant’s sole remedy is to request the opportunity to resubmit its Submission, which request will be determined at the sole discretion of the Administrator if the Call for Applications Submission Period is still open. 

10. Publicity 

Participation in the Call for Applications constitutes the Applicant’s consent to the use the Applicant’s name and description and, if applicable, the likeness, photograph, voice, comments and/or hometown and state of residence of individuals who participated in the Submission, in connection with the Program in any media, worldwide, without further payment or consideration, for a period of ten years following the conclusion of the Rapid Pilot Study or Call for Applications, whichever is later. 

11. General Conditions

• The Administrator reserves the right to cancel, suspend and/or modify the Call for Applications, or any part of it, if any fraud, technical failure or any other unanticipated factor or factor beyond the Administrator’s control impairs the integrity or proper functioning of the Call for Applications, as determined by the Administrator at its sole discretion. The Administrator reserves the right at its sole discretion to disqualify any individual or Applicant it finds to be tampering with the Call for Applications, specifically including but not limited to the entry or voting process (for example by using the aid of computer software programs to auto-fill entries) or the operation of the Call for Applications or to be acting in violation of these Official Rules or in a manner that is inappropriate, not in the best interests of this Call for Applications, or a violation of any applicable law or regulation. The rights described in this paragraph are supplementary to and in no way limit or diminish the rights described in paragraph 1 1 (E) below or elsewhere in these Official Rules.
• Any attempt by any person to undermine the proper conduct of the Call for Applications may be a violation of criminal and civil law, and, should such an attempt be made, the Administrator reserves the right to take proper legal action, including, without limitation, referral to law enforcement, for any illegal or unlawful activities. Updated: February 13th, 2023
• The Administrator’s failure to enforce any term of these Official Rules shall not constitute a waiver of that provision. The Administrator is not responsible for incomplete, late, misdirected, damaged, lost, illegible, or incomprehensible Submissions or for address or email address changes of the Applicants. Proof of sending or submitting will not be deemed to be proof of receipt by the Administrator.
• In the event of any discrepancy or inconsistency between the terms and conditions of these Official Rules and disclosures or other statements contained in any Call for Applications materials, including but not limited to the Applicant Submission form, Call for Applications website, advertising (including but not limited to television, print, radio or online ads), the terms and conditions of the Official Rules shall prevail.
• The Administrator reserves the right, without liability, to amend the terms and conditions of the Official Rules at any time, including the rights or obligations of the Applicant, the Sponsor and the Administrator. The Administrator will post the terms and conditions of the amended Official Rules on the Call for Applications Website. Any amendment will become effective at the time the Administrator posts the amended Official Rules.
• Excluding Submissions, all intellectual property related to this Call for Applications, including but not limited to trademarks, trade-names, logos, designs, promotional materials, web pages, source codes, drawings, illustrations, slogans and representations are owned or used under license by the Administrator. All rights are reserved. Unauthorized copying or use of any copyrighted material or intellectual property without the express written consent of its owners is strictly prohibited.
• Should any provision of these Official Rules be or become illegal or unenforceable in the jurisdiction of a permitted entrant, such illegality or unenforceability shall leave the remainder of these Official Rules unaffected and valid, the illegal or unenforceable provision shall be replaced by a valid and enforceable provision that comes closest and best reflects the Administrator’s intention in a legal and enforceable manner with respect to the invalid or unenforceable provision.