5 steps to launch a Precision Health Test

Very seldom do people focus on the process, details, or steps involved in launching precision health tests as a product. Instead, their main focus has always been the biological and scientific aspects involved in precision health.

However, rather than dwelling on the clinical laboratory angle or the algorithm of interpreting the test, this article will limit itself on the process and procedure of launching the complex test as a digital product. The article will delve into the challenges, the necessary resources, the cost, as well as the integration matrix for launching precision health as a product.

 

DATA IN PRECISION HEALTH

It is safe to argue that the process of launching preventive precision health care as a product is solidly founded within the precincts of data.

The evolution of the health care system all over the world has allowed precision health to restructure and reinterpret the scope of medicine. With precision medicine, diseases can now be accurately determined, predicted, averted, and even treated. Therefore, to create an elaborate integration matrix to launch the product, clear guidance on definition and design is necessary.

 

1. Product Definition and Design

This is a very critical aspect of product development as it entails giving the user guidelines and defining the user experience. As we all know, the evolution of genetic treatment coupled with specificity and accuracy has enabled the delivery of achievement of treatment options that are highly operative and effective. 

 

Step 1: Defining the Product

Through the process of product definition, the client base can be easily defined. This process necessitates that a clear definition of the business necessities and strategies be laid out. This includes a well-defined product value, the customer base, pricing approach, and attributes of the product.

This is important for the provision of patient-specific treatment, a key pillar of precision health. The provision of new and existential definitions is necessary for the advancement of newer and better versions of targeted drugs. Since the delivery of patient-specific and customized medical care packages is largely reliant on the evidence-based healthcare restructuring the acquisition of health data that is fine-tuned happens to be one of the targeted action plans. 

This phase of defining the product is an elaborate process that takes between 1 and 3 weeks. The stage requires some crucial skills and human resources. This personnel is the legal counselor, business development manager, content writer, product manager, and the UI/UX Designer.

 

Step 2: Guidelines and Content Creation

This is yet another very crucial stage that takes an estimated 4 to 6 weeks to complete. It is where educational material, legal documentation, as well as the personalized action plans for the final customer are made. The education materials might include post-testing guidelines, test results guidelines, etc. The legal document contains Privacy policy, HIPAA regulations and consent, the terms of service, and many more. 

With personalization and customization of medicine, the need for copious and vibrant molecular data, health data and clinical-generated patient data have fueled the potentiality and assurance that even greater milestones will be achieved in preventing and treating even worse conditions. As such, in the process of launching the product clear educational measures and guidelines needs to be provided to the end-user. In this regard, the legal team, the content writers, and the UI/UX designer are very important personnel and resources of this stage.

 

Step 3: User Experience and User Interface Designing

In this stage, the UI/UX designer will take from 4 to 6 weeks to:

1. Conduct user research
2. Define the user focus groups
3. Design the user interface (UI)
4. Brand guideline implementation
5. Patient-flow experience test and refinement
6. Ascertain the quality of the written content
7. Test the product’s usability
8. Ensure that the end product matches the written content and design in terms of looks and feel.

 

Using Data Visualization To Unlock THE VALUE OF DATA

To unlock the value of the user’s data, genetic data visualization instantly enables the presentation of complex datasets to be brought down to the layman’s level. And rather than encountering complicated terminologies like phenotypes and genotypes, the individual is presented with user-friendly information. This intuitive genetic data visualization allows the user to gain a deep understanding of the data assets at his disposal.

 

2. Platform development (ENGINEERING)

There is a need to engineer a product that will not only be patient-specific but also user-friendly. The following are the steps of the engineering phase:

 

Step 1: Front-End Development

This step involves the development of a visible User Interface. For 8 to 12 weeks, project managers and front-end engineers use various JavaScript to develop a web and mobile web interface. The frameworks involve the creation of patient portals, versatile UIs, APIs, email templates, and the admin portal. Engineering of this phase must always be preceded by the creation and design of content. 

The following pages should be incorporated into the patient’s portal:

1. Home Page
2. Frequently Asked Questions (FAQ) Page
3. Sign-in Page
4. Password Reset Page
5. User Experience Page
6. About Page
7. Product Pages
8. Terms of Service
9. User Consent Page
10. Kit Registration Page
11. Registration Page
12. Verify Email Page
13. Profile Info Page
14. Profile Pages
15. Result Page(s)
16. Research Consent pages
17. Orders page
18. HIPAA Consent Pages
19. Error Page
20. Dashboard Page
21. Pre-Result Consent Page
22. Result List View Pages
23. Health History Questionnaire Page
24. How it Works Page
25. Sample Collection Page
26. Result PDF
27. Post Result Education Pages

 

Step 2: Back-End DEVELOPMENT

Needing an estimated 2 to 4 Back-End engineers, security engineer, and the project manager this engineering phase takes between 4 and 6 months to complete. These are some of the features developed in this phase:

1. Business logic
2. The architecture of the database
3. Development of: 
   1. Patient Portal 
   2. Staff Portal
   3. Admin portals
4. User dashboard
5. 3rd party API and network integration
6. Result delivery interface (Digital and printable format)
7. Electronic consent implementation
8. Patent status and sample tracking
9. Kit Registration
10. User authentication, registration, and returning user sign-in flow
11. Genomic interpretation setup
12.  Bioinformatic functionalities (imputation, annotation, etc..)
13. Notification service implementation
14. Checkout flow
15. Surveys and health questionnaires
16. Implementing Tracking system
    1. Sample Tracking
    2. Patient status tracking

 

Step 3: Cloud Engineering

The first phase of cloud development is the HIPAA cloud phase which should take an estimated 4 to 6 months. The personnel in this phase include the cloud and security engineers and the project manager. The phase must adhere to the Business Associate Agreement (BAA) regulations, as well as the cloud audit for compliance.

The following steps are crucial to setting up a HIPAA cloud:

1. Seek the services of the Department of Health and Human Services and the OCR to find a thorough Cloud Service Provider (CSP). Thereafter, with the legal team, create a Service Level Agreement (SLA) and a BAA that is in line with all HIPAA regulations. 
2. Data security: HIPAA demands that specific measures should be implemented to protect patients’ data. These measures include: 
3. Strong and powerful passwords
4. Two-factor authentications
5. Powerful firewalls
6. A program to detect intrusion
7. High-quality data encryptions
8. Introduction of session timeouts

Breaches: In case of a breach into the system and the patient’s ePHI is compromised, within 60 days the patient should be informed of the breach. Every PHI breach should also be brought to the attention of the Department of Health and Human Services.

 

3. Third-Party Service integrations

In this 21st century, healthcare has evolved to heavily rely on data as an asset of immense value. The value of health data can be traced back to the understanding of the functional characteristics of human beings. The process of launching precision health in which data is of crucial importance call for the need to integrate third party services.

 

Customer Relationship Management (CRM) Services Integration

Consultation between CRM service providers and the engineering teams is a necessary ingredient in communication when developing precision health solutions. CRM services are crucial as they allow developers to develop a functional customer relationship. The Project Manager and CRM Salesforce Engineer, are the most important persons in this process and will take approximately 4 to 6 weeks.

The patient journey includes the following steps:

1. Ensuring the correct user interface is displayed
2. Process state machine tracking
3. Ensuring the correct information is sent out on the basis of each state

 

A CRM tool can have the following patient journey state set up in it:

1. Kit created
2. Health QA approved/rejected
3. Kit registration
4. Kit received by Lab
5. Kit analysis complete
6. Kit data ready
7. Kit unusable or damaged
8. Kit voided
9. Kit result approved/rejected
10. Kit result ready

 

Notification Services Integration

The main features of notification are emails and text messages which entail reminders and follow-ups, platform and engagement notifications. Engineering teams usually integrate their product with Twilio or MailChimp. In this phase, the back-end engineer and the project manager will take a maximum of 2 weeks to create the system and integrate functionalities like:

1. User phone number enrollment
2. Status change notifications
3. Phone number verifications
4. Un-enrollment

E-Commerce Service Integration

Platforms like Stripe, Shopify, and Magneto play an important role in the checkout, inventory management, and e-commerce. This phase takes the project manager and back-end engineer between 1 and 2 weeks to integrate. Shopify, which is one of the most elaborate e-commerce platforms can be linked to the system using the following instructions once you have an account, store URL, and Shopify credentials:

1. Open a set-up page in Vend then click the Add-Ons
2. Locate Shopify and then Add to Vend
3. Type your Shopify Store URL
4. Enter your Shopify log-in credentials

 

Precision Health Lab Integration

Every health testing product has to be integrated with the Lab Information Management System or the Lab API. Precision health testing labs Integration necessitates that Backend Systems and Lab Systems have to communicate to enable the following processes: 

• Kit registration
• kit Cancelling 
• Sequencing Status Notifications 
• Results in Notifications 
• Sending Results 
• Error Status Notifications

This phase of launching seeks the services of a Bioinformatics Engineer, the Project manager, and the Backend Engineer. The whole phase takes between 4 to 8 weeks.

 

Fulfillment Services Integration

This phase will take the Project Manager and the Backend Engineer an estimated 2 to 3 weeks to integrate with a fulfillment center to offer shipping and tracking services. This process includes:

1. Having a sample collection box designed
2. Selection of a sample collection device and the shipping mode
3. Obtaining all the information on shipping and tracking the shipment

Electronic Health Record (EHR) Integration

EHR is a preferable means through which precision health solutions can be launched. This call for the consolidation of the following functionalities which will enable successful integration of Precision Health Testing and the EHR system:

1. Ordering test
2. Clinical Decision Functionality test approval
3. EHR Status Notification
4. EHR Report uploading and viewing
5. EHR test sign-off

The necessary resources of this phase are the Project Manager, the BAA, and the Healthcare Systems Engineer. This will take them between 8 to 10 weeks.

Two important standards for precision health data exchange include:

1. Fast Healthcare Interoperability Resources (FHIR)
2. Health Level Seven (HL7) set the standard

 

Interpretation Services Integration

This process will take the Project manager and the Backend Engineer and estimated 1 to 2 weeks. In this phase, the engineer will apply the FASTQ, VCF, and JSON formats to have a webhook notification service in the interpretation process.

 

4. SECURITY AND DATA PROTECTION

With the unprecedented and growing concerns regarding the rising cybersecurity incidents and threats, it will be very imprudent if guidelines regarding precision health are not spelled out. 

Implementation of Security Regulations

Implemented by the Backend, Frontend, and Security Engineers, this phase involves the integration of very high-level security features. The whole team will take a maximum of 8 weeks to develop:

1. Security practices development
2. Data encryptions
3. Cloud infrastructure security
4. Administrative controls
5. Physical controls
6. Server Security Practices (AWS)
7. Human Resources security
8. Incident Management
9. HIPAA standard practices, etc

GDPR and CCPA compliance

The California Consumer Privacy Act (CCPA) and the General Data Protection Regulation (GDPR) compliance offers protection measures and general rules involving patients’ health data. These rules are particularly strict for health and genetic data which are categorized as particularly sensitive mostly for EU citizens and California citizens. The integration of these regulatory acts into the system involves cookie consenting, data collection authorization, etc. The process takes 3 to 6 weeks to implement and requires the services of a Project and Regulatory managers as well as the Frontend and Backend Engineers.

 

Clinical Oversight

The Clinical Laboratory Improvement Amendments (CLIA) are the main regulations that govern precision health tests since they are all Lab Developed Tests. This phase can be accomplished by the medical practitioner who has contact with the patient. It can also be conducted by a board-certified provider network with the assistance of the Health History Questionnaire, Health History Questionnaire Approval/Rejection, and the Results.

The significance of the Health History Questionnaire is the approval of the end-user for the test. Thereafter, The LDT APIs will be used to send the questionnaire responses for approval. 

The Health History Questionnaire Approval/Rejection allows the provider to either approve or reject the test on the basis of the received questionnaire responses.

The Results will be availed in the system for the provider to sign off once the tests are completed by the lab and the results are ready.

 

5. Pre-launch of a precision health testing platform and Ongoing Operation

The end-to-end alpha and beta testing are necessary before the product is launched to the market. This way, any bugs on the product can be detected. Thereafter, a 24hr monitoring on the product is needed. This is done by the DevOps team where they monitor every update, analytics on the platform changes documentation, and much more.

The following are the functionalities of the operation and monitoring team:

1. User data access
2. Updating the platform
3. Source codes logs and systems alert proactive monitoring
4. Security patching
5. Managing the source code control
6. SSH/SSL Key and Certificate management
7. Documentation of changes to the systems, procedures, or even processes
8. Continuous integration management

 

ixlayer the complete Precision Health Testing platform

ixlayer product and engineering teams have built a comprehensive solution to easily cover all these steps. Ixlayer is an end-to-end platform where biopharma companies, clinical labs, and consumer brands can offer their patients precision health services after every other step has been completed. 

ixlayer is a robust platform where precision health care is realized by utilizing health data in a manner that simplifies the clinical health test. Taking into consideration the fact that health data can be broadly categorized as either dynamic or static, ixlayer compounds a blend of the two data types to the patient’s benefit and makes the patient the focal point thereby attaining the desired action plans stemming from the personalized recommendations.