What is WHISE?

WHISE is an idea!

An idea to empower patients and put them in control of their healthcare.

Before we explain the idea, let us tell you a story that re-examines how healthcare works today, tells you about stakeholders, emphasizes what is broken and proposes what it takes to fix it.
Along the way you will learn some of the vocabilary used by healthcare professionals and will be able to make sense of it.
Our story is centered around the single, most important instrument of 21st century medicine:

IT IS ABOUT YOUR MEDICAL DATA

The healthcare enterprise starts and ends with patients!

When we, humans get sick and visit a doctor, we are called patients.
We get diangosed, get lab results; we develop a treatment plan with our doctor; end up consuming healthcare products.
Sometimes, when we encounter uncurable conditions, we participate in clinical trials as a last chance resort; we rely on science and cutting edge technology hoping that it will help elongate our lives or discovere a cure.
We try to sustain or recover health and along the way pay for everything not just by our money, but with our time, our health, and the support of our families and friends.
Ultimately every patient gets old, health deteriorates and eventually we arrive to the end of life.

Regardless of our origins, our wealth and abilities, our positions and networks; you might be an executive of a large bank or janitor, a school teacher or a president, a doctor or student;

in the eyes of a disease - all of us are patients in our journey of life!

Your doctor is your trusted partner working for you!

During your visit, the doctor decides what analyses should be performed.
He or she then refers you to different labs for specimen collection and measurements.
Upon arrival of the data from labs, the doctors interpret it in order to diagnose and treat you.
You phycisian then bills you and your insurance company by sending specific treatment and disease codes.
You doctor then follows up with you to make sure you are better or haven’t gotten worse.
The information generated on the patients’ behalf during the entire process is then reported by doctors and nurses into medical record databases.
This information has an immense value for your own future health and can be used for designing new treatments, new drugs, new devices through scientific research and engineering.

Hospitals and clinical facilities provide critical infrastrucutres!

Behind every patient, every bed, every desk, every drug there are countless people working for you: doctors, nurses, technicians, janitors, electricians, drivers, IT personnel, accountants, and many others. A hospital is a complex business of running operations centered around your healthcare when you are sick.

As a result, and in order to provide continuity of care, hospitals aggregate medical histories longitudinally (over time) as a true reflection of patients health. These “Real World Evidence” datasets might be shared with research partners and eventually with the FDA to evaluate existing treatment efficacy and safety.
However instrumental, the patient data frequently is not in a shape (non-standardized) to be transferred and used across different clinical facilities even within a single hospital. This sometimes leads to mallpractice, litigation and detestable waste of human life and unnecessary expences of time consuming duplicative measurements. There is no incentive for hospitals to clean the data on patients behalf. There is a lack of economic value in patients data secondary use without patients consent. It is cheaper and less burdensome to trade deidentified and poor quality data without patients knowledge, instead of spending resources in generating high quality integrated data with patients consent.
Without patients further consent (agreement) the immense value of data can not be truly unlocked to help design new drugs and new treatment options by researchers.
Regulations protect patients’ rights (rightfully so) to own and control the data use, but not having actual ownership prohibits patients to participate in comprehensive and knowledgable data sharing.
You as a patient have a right to your data, but no technological means to access it, no legal policy framework to enforce it, and no incentive to cooperate.

Health insurance is a business of oilling the healthcare machine!

The insurance industry collects the money from the patient population at large (healthy or not) in form of premium payments.
Based on internal expertise and prior risk data assessments they evaluate claims of doctors and labs that had provided services to patients, and make decisions if and how much to pay.
The industry evaluates how much you and others cost to the business to factor in your expences for determining the future risks and premium costs for the next cycle.
Unfortunately, insurance companies frequently lack data to make qualified decision on efficacy of treatment options and are forced to pay for drugs that do not help patients, and sometimes pay to clinicians who are not doing well.
Some estimates indicate that about half of the payments (many 100s of billion dollars per year in US alone) are for treatments that do not help patients, but patients are paying for it.
Payors are an important part of the healthcare enterprise. In order for the entire enterprise to work, it must be economically sustainable. That is why access to health data is critical for the decision making process.
There is an exacerbated fear amongst the patients that insurance companies might refuse future coverage due to potential post-conditions based on your data. It is imperative to mention that savings generated by proper evaluation of treatment options based on scientific data far outweigh the cost of covering pre- and post-conditions.
For patients as well as for insurance companies it simply makes economical sense to have data driven healthcare payment options.

We need pharmaceutical, biotechnology and device industries!

It takes astounding amount of work of large number of scientists and engineers to invent a single new drug or design a medical device. To turn an idea into a working prototype and then into a product it takes humongous efforts from engineers, technologists, clinicians and businessman. In order to bring the product to a market, it takes even more efforts from a variety of professionals with vast expertise in business, accounting, medicine, marketing, etc. Behind a single tablet that you take — there are thousands of lifes, inspirations, hard work, devotion, billions of dollars, and hopes.
To discover the next therapeuitic candidate molecule or a device the medical product industry needs big and varied types of data from multiple segmented sources. They frequently generate data through expensive scientific research as well as Real World Evidence (RWE) generation by phycisians during or after clinical trials. Largely because of this need, an average cost of the drug hitting the helath market is about 3 Billion dollars these days (2019).
Clinical studies require phenotypes (such as health status, demographics, outcomes), imaging (X-rays and MRIs of tissues), lab results (blood, cytology, infections), genotypes (genes of normal and tumor tissues) and many other types of information from different sources along the progression of a desease.
You as a patient are the only one who is legally allowed to aggregate and freely decide the fate of your data: the valuable asset that you legaly own, but have no means of ownership.
But you as a patient have thousands of worries to take care after you are out of the hospital. Without proper incentives, without technological means, without policy support you have no time and no motivation to aggregate and share your data to support the pharma and insurance industries.
The truth is that pharmaceutical and medical device research and development are expensive: scientists need to generate large and diverse biomedical data to conduct reasearch and discover the next treatment options. And you, the patient is the only person who can truly empower science by providing incentivised access to your data.

The regulators guard your interests!

Food and Drug Administration (FDA) and other regulatory bodies around the world are built to protect patients’ and consumers’ interest through regulation of healthcare markets. These organizations employ some of the most outstanding bright scientists to critically analyze the medical claims of commercial products, ensure their safety and efficacy. The entire regulatory process is protocolized in controlled stages to make sure all checks and balanaces are in place.
Preclinical: After confirming if the drug works on a tissue extracted out of human body (in vitro) it is tested on animals like mice (in vivo) to test if it has no poisonous (toxic) effects.
Phase 1: Study of safety by analyzing patient level data to ensure no harm can be done. Next is study of metabolism data to understand how the drug is consumed and distributed in patients body.
Phase 2: Study of efficacy by screwtinizing patient level data to make sure it is not just a placebo effect (patients feeling good merely by thinking they are given a medication) and has actual pharmacological effect.
Phase 3: Study of data to determine the treatment dosage (amount and frequency of drug administration) and comparatives with alternative methods of treatment.
Approval/denial: It is a formal decision that determines the fate of the treatment or a device to be marketable as a medical product.
Phase 4: Continous collection and analysis of Real World Evidence data from clinics to ensure the drug performs on the market as expected and no significant negative effects are observed.
FDA is a data hungry algorithm.The entire regulatory machine behaves like an algorithm: it accepts data and produces decisions based on judgment of experts assisted by computational methodologies. And just like any algorithm it needs clean and high quality data to make qualified decisions.

21st century is all about data: let us reiterate!

Doctors need integrated, high quality, longitudinal data from different clinical systems and labs to ensure valid and timely treatments.
Hospitals need integrated, high quality, longitudinal data to organize the business better, save money and costs.
Insurance companies need integrated, high quality, longitudinal data to make better decisions on payment options and save money and premiums.
Pharma and device industry needs integrated, high quality, longitudinal data to come up with right targets , new medicines and new treatments.
Regulators need integrated, high quality, longitudinal data to facilitate approval process and bring drugs to market quicker.
We the patients are the only stakeholder who has the biggest stake and permission to provide integrated, high quality, longitudinal data perspective to our health. Yet we have no technological means, policy support, and market incentive vehicles to do so for our own sake.

Health is about us, about our aging parents and well being of our children, about our dear friends, neighbors and everyone else: health is personal.

How do we make our health data work for our health?

WHISE idea: patient should be in control!

The steps to make WHISE work on patients’ behalf:
Find patient data: work with hospitals, clinician networks, pharma, insurance companies and clinical trial investigators to allocate patient level data, clean it, standardize it, store it in most secure distributed data ecosystems.
Re-grant data ownership to patients: match patients to her/his data and invite the patient to re-claim ownership of the data in its entirety at no cost.
Marketize the data: with the patients’ consent allow consumers (pharma, biotech, device manufacturers, insurance) to see limited subset of patient phenotype and disease status data in order to generate significant interest.
Monetize data access on patients behalf: serve as marketplace where patients and their doctors can sell time-limited access to use their data for a particular agreeable and consented purpose such as clinical research or a regulatory review.
Provide regulatory compliant analytics: with the patients’ consent extract biomarkers (signifying a potential disease or treatment alternative) to enrich patient data with derived analytics.
Monetize derived information on patients behalf: allow patients and their doctors to sell derived health analytics results to pharma and insurance industry for accurate perspectives of treatment options and future drug targets.
Provide technological base for data transactions: allow patients and their phycisians to share the data at cost or no cost across healthcare systems.
Provide connection to regulators: with the patients’ consent allow regulators to retrieve patient information directly from clinical networks to continuously monitor their health and impact of marketed drugs and devices.

Patient in equation: why does it make sense for all stakeholders?

Today the legal framework and regulations prohibit integrated and identifiable data re-use without patient consent. Therefore all such transactions that happen today behind patients back with segmented and de-identified data elements are of low quality and are very expensive.

Allowing patients to be part of the healthcare data economy can liberate data and create a competetive marketplace where data access and analytics are offered as commodities.
Patients can be incentivized to aggregate data through WHISE supported platforms and share with potential consumers of data at cost or no cost.
Pharma, Biotech, Device manufacturers and other research organization can purchase data to build a holistic and longitudinal access to integrated data in order to recruit patients and perform large scale studies.
Industry can trade some of the clinical data in order to partially recover the costs of failed trials while paying patients for a consent.
Pharma can find doctors and their patients that are best fit for newly licensed drugs through purchasing patients data instead of large and expensive advertisment campaigns.
The insurance industry can purchase consented and mutually beneficial access to biomarkers and make qualified decision on devices, drugs and treatments.
Regulators can get timely access to data about medical products that are currently marketed by directly working with patients and patient advocacy groups.

With patients in charge we can build a marketplace that is an economical non-zero sum game benefiting all parties.

That is our WHISE idea!

The WHISE approach.

Incentivize patient ownership to facilitate exchange of personal health data by patients and their clinicians for monetary benefits or for exchange of healthcare goods and services.
Architect policy framework to support e-consent and exchange of identifiable and connected data from disparate sources without legal limitations.
Initiate a marketplace by connecting patients, clinicians, owners and consumers of health information for mutually beneficial transactions.
Aggregate health information atlas for linking data back to patients’ databank account from variety of sources: medical history, genomics, wellness, etc.
Technology developments of distributed software and hardware architectures providing highest level of security, privacy and consented, certifiable and auditable availability for the data as well derived information.

Ownership, Policy, Marketplace, Information, and Technology: 5 instruments to achieve a single noble goal of benefiting patients while transforming the industry.