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European Biopharmaceutical Review

Critical Overhaul

Now more than ever, patients are playing a more active role in their care – from demanding visibility as to the costs of medical services, to interacting with physicians regarding new ways to participate in preventive care measures. Governments, pharma companies and providers have all recognised that turning patients into educated healthcare consumers is increasingly critical to overhauling the system by driving down costs and improving outcomes. At the same time, the healthcare industry will be forced to change if patients continue to be a driving force in the commoditisation of personalised medicine – and hospitals will soon be impacted by this increasing demand.

The recent investment made by the University of Pittsburgh Medical Center (UPMC) health system in Oracle and IBM technologies marks just the beginning of a critical shift. Providers have recognised that very soon, as the cost of genome and exome analysis becomes increasingly affordable, patients are going to demand therapies and treatments designed specifically for them. However, with their myriad of broken policies, siloed electronic medical records, health information exchanges and mobile device data, most health systems today are not equipped to house, manage, share and analyse the data they possess now – let alone the large volumes of data required to provide a more personalised service to patients. As patients become more involved in their care, and expect more from their health systems, they will drive the market by choosing hospitals which can customise the most efficacious therapies.

As a result, the hospitals and health systems that will win out will be those that can think big about what patients will be demanding in the not-so-distant future, and then effectively make the changes necessary to make it happen. Regulators will also need to develop to facilitate these changes. While the pharmaceutical industry will remain focused on evolving clinical development – including tapping into new patient populations through hospital technologies – the entire health industry is becoming connected and interrelated, and the patients will benefit. Ultimately, companies will sink or swim based on their ability to meet the inevitable demand for better, more personalised patient care.

Interoperability and Big Data

Patients are demanding access to their records in order to get a better understanding of their health. They are expecting that their doctors have access to their full medical histories and incorporate that into the health decisions they make. Patients are also looking to augment their data with devices that record their movements, fitness and blood sugar levels, or other metrics.

Unprecedented amounts of data are being collected, and this volume continues to drastically increase. We are starting to see new types of data available, such as genomic and new test data that are hundreds of thousands or millions of data points (sometimes even much larger). Different systems are used to collect each kind, and being able to combine them is becoming increasingly important.

When a doctor is preparing to make a diagnosis, it is imperative that he or she has access to all available data about the patient. Not just the electronic medical records, but also data from other providers, medical histories from past providers, blood work and genetic information, when available. These all need to contribute to the decisions that doctors make. However, today that information is locked away in silos across different systems.

Another real challenge is that personalised data is big. Really big. Being able to gather all of the tests and genetic information we can now extract is difficult – let alone store it or analyse it. However, as technology continues to improve, it will become more and more practical to work with these large personalised datasets and to interact with them in useful ways.

The cloud will become extremely important in figuring out how to handle and process this amount of data. Primarily, the cloud allows companies to take advantage of economies of scale, so that they can allocate a large amount of computing resources to solve a problem when necessary, but not waste that power when it is not. The cloud can also be cost-effective in these cases, allowing companies to only pay for what they use. Also, this data is important in other ways. By collecting big data, combining these data systems and looking at them in aggregate, the healthcare industry as a whole will be able to help patients by understanding diseases, drug interactions and other important issues. For example, being able to look at larger sample sizes will enable us to discover new treatments and identify potential problems with existing ones. Data interoperability – an area that all healthcare entities struggle to achieve – is key, because it is what will drive our future understanding.

Better Incentives

Before the industry will see any success in personalised medicine, it is critical that health leaders work to better align incentives. It is obvious that the current incentive structure in the US healthcare system is extremely skewed. For example, care providers and hospitals are incentivised on volume – so they are financially rewarded for seeing more patients, keeping them in the hospital longer, and essentially keeping them sick. In addition, subsidies that hospitals receive in one area often prevent them from earning more money in other areas. For instance, the emergency department is often a cost centre, while the operating room is a profit centre.

Many of the recent legislation changes in the US aim to change these incentives and motivate health systems to keep patients out of the hospital. For example, accountable care organisations will be penalised for patient readmissions. But the challenge in reducing readmissions is that most providers rarely have any interaction with patients once they are sent home. These types of incentive discrepancies make it very difficult for hospitals to function properly.

Compound this with the other misaligned incentives which exist, and the provider environment is simply not conducive to experimenting or taking risks, and often resists transparency. Of course, with personalised medicine, transparency and accuracy is extremely important. With the practice of personalised medicine, it is inherently difficult to determine whether or not negligence was involved, if and when a catastrophic event occurs. So with misaligned incentives that focus on dollars in the door versus innovation, doctors will shy away from personalised medicine approaches because of a lawsuit risk.

New techniques, such as evidenced-based medicine, go some way to alleviating these concerns: doctors can substantiate decisions with objective ‘evidence’, to make sure that their diagnoses are defensible years later. For certain fields, like interventional cardiology, evidenced-based medicine is extraordinarily important because often things go wrong years down the line. In reality, interventional cardiologists are usually dealing with patients who are not in great shape, and so cardiac events are unavoidable. However, objective metrics need to be put in place to defend against any future lawsuits. The problem here is that, currently, doctors are incentivised not to help patients.

Augmenting Doctors

Once we have real interoperability and appropriate incentives, there are some amazing tools that the industry will be able to create and use on a large scale. For example, researchers at IBM are working on ways to have super computers analyse all available medical papers and transfer the results back to a specific patient. IBM’s Watson, which can read over 60 million pages per second, is now being fitted for use by doctors, where it will be able to read all available data and provide doctors with a prioritised list of what it thinks is relevant to a particular patient.

What is extremely powerful about this is that it will enable personalised medicine on a level that was previously impossible. Doctors will no longer be expected to be the oracle of all information, nor should they be. Instead, they will become extremely skilled at using tools that both feed the appropriate data and interpret the results, in order to deliver highly personalised, relevant answers to patients. They will even be able to leverage research that was published just days prior to their diagnosis, to make sure that the patient is getting the best available treatment.

Eventually, doctors will become stewards of amazing technology, similar to the way that Google is currently used by all professionals to help augment their jobs. Human intuition is still an extremely important ingredient needed to direct the powerful technology in development. But the technology will augment it in such a way that hyper-personalised medicine will become possible.

Greater Insights

Above and beyond what has already been mentioned is that the healthcare industry needs better tools to extract information from data: data of varying levels of granularity, compensating for many inconsistencies. Not just that, but every person involved with patients and the personalisation of medicine – patients, doctors, radiologists, the IBM Watson supercomputer, and so on – needs to extract different answers. Figuring out how to make all this work is an extremely difficult task, but there are companies and projects that are showing immense promise. Insights need to be executed in real-time and done in such a way that every user gets the answers they need without wasting precious time having to prepare them.

Privacy Issues

One of the largest problems with personalised medicine is privacy. In order to accurately implement personalised medicine, keeping and working with personally identifiable health information is a must. Doing this on a large scale is extremely problematic, but there are also other details which can make it even more evasive. For example, once you start combining medical histories, financial details and genetic codes, companies and governments will gain complete access to every detail of this data. Using this in malicious ways, or if it gets into the hands of the wrong people, can be disastrous.

The solution to these privacy issues are technological innovations that pass around privacy information as metadata, and systems that respect and utilise it. New tools and techniques can ensure that private information is kept private, while still being used to maximum advantage. Digital data can be exceptionally secure, but it is important that hospitals partner with modern service providers and vendors to take advantage of the latest privacy protection advances.

Conclusion

The healthcare industry will continue to see increasing demand from patients looking for personalised care and therapies. But before providers or pharmaceutical companies can reap the benefits of personalised medicine, the industry needs to continue on its path towards achieving interoperability among systems, leveraging the cloud to manage and secure insights into big data and better aligning incentives to reward providers for innovation. While it will not be achieved overnight, the technology is available today to make it happen.


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Rick Morrison is Founder and CEO at Comprehend Systems, where he is responsible for the overall direction and management of the company. In 2012, he was named in the PharmaVOICE 100, which recognises the 100 most influential people in the life sciences industry. Prior to Comprehend Systems, Rick spent nearly a decade developing clinical analytics tools, including tools used by the FDA and top pharmaceutical companies. He holds a BA in Computer Science from Carnegie Mellon.
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