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10 Articles in Volume 17, Issue #10
A Guest Editorial on Counterfeit Pain Medication: The Other Epidemic
A Model to Incorporate Functional Medicine into Chronic Pain Care
Chronic Pain and Substance-Related Disorders
Getting at the Root of Opioid-Induced Constipation (OIC) with an Osteopathic Approach
Inside FDA's Guidance on Generic Abuse-Deterrent Opioids
Neural Pathway Pain — A Call for More Accurate Diagnoses
Pain Care in a Natural Disaster
Pharmacological Interventions in Sport-Related Concussion
The Internet of Medical Things
What Type of Withdrawal Symptoms from Tramadol Might a Patient Experience?

The Internet of Medical Things

Connectivity, sensors, and big data could soon revolutionize quality-focused patient care, compliance, and payment models for pain care physicians.

Technology and healthcare have converged so completely that practitioners may soon be able to “spy” on their patients. Case in point, FDA recently approved a pill (aripiprazole tablets, Abilify MyCite, Otsuka and Proteus) equipped with an ingestible sensor that tracks whether a patient has swallowed it.1 In an age where medications track patient compliance, pedometers send data to Smartphones, and patients can flip a switch in attempt to block pain, what more might the future hold?

The answer, experts believe, may come in the form of the Internet of Medical Things (IoMT). Coined after the 1999 term “the Internet of Things,” the concept of interconnectivity across daily lifestyle devices has expanded to the healthcare industry. The prospect of vast waves of medical data flowing between patients’ devices and healthcare providers has the potential to transform not only R&D and regulatory compliance, but also patient care and physician payment models.

Connectivity to Improve Research

“One of the advances we are going to see going forward will be a ‘cloud’ where researchers can draw data,” said Timothy Deer, MD, president and CEO of the Center for Pain Relief in Charleston, West Virginia, and president of the International Neuromodulation Society. “That means if there’s a short on the device, we can retrieve the information. But none of the companies that make these devices have a way to access it remotely” to date.

Currently, data from a medical device travels only to the physician’s linked computer. As an example, Dr. Deer described a patient with a structurally successful knee replacement surgery who was experiencing ongoing pain. “We would put a little wire on that part of the spinal cord to change the signal and block the pain signal so [the patient has] a lot less pain.” This wire would come from a neuromodulation device called a dorsal root ganglion (DRG) stimulator.

“We can set the computer settings ourselves, but we give the patient a remote control that they can use; if they’re having a good day, they may want to turn it off.” Doctors tracked data from experimental DRG use during clinical trials, said Dr. Deer. The early study demonstrated safety and provided benefits to both patients and physicians.

Dr. Deer is participating in a study for an Australian company (Saluda Medical) that measures the spinal cord’s reaction to electricity. “We can actually have the computer respond back to the response from the spinal cord. So there are real-time changes in the computer based on the patient’s response. This is not FDA approved yet, but it’s going to be potentially really good for patients.”

“Eventually, there will be a cloud-based mechanism for all these devices,” he said, although the unresolved question is who may pay for the expanded digital access. Tracking and comparing outcomes throughout different populations is a valuable goal, he added.

The International Neuromodulation Society seeks to deliver on this concept by fostering collaboration among countries and examining outcomes with an eye toward improvement. However, said Dr. Deer, “finances have been somewhat limited, and spent toward research on new devices and advancing current devices.”

Sensors Abound

Biosensor technology is another area within the Internet of Medical Things (IoMT) that is “set to explode,” according to Tiziano Marovino, DPT, MPH, DAIPM, senior vice president of health strategy and innovation for the Biogenesis Group in Ypsilanti, Michigan. Embedded in wearable devices, biosensors are already able to capture basic data such as heart rate, caloric expenditure, sleep time, and step numbers. Wearable sensors will soon “become an integral part of disease management, providing even more health data to their medical providers,” he said.

In addition, implantable sensors may soon be able to track health- and disease-
related markers. “Micro-electric mechanical systems (MEMS) are now a part of virtually everything electronic that requires monitoring and transmitting,” said Dr. Marovino.

“In medicine,” he added, “MEMS devices can be scalable chips inserted just under the skin to sense, monitor, and communicate important information. One application is the insertion of MEMS into a disposable contact lens. The MEMS acts as a strain gauge and a microprocessor, so it monitors intra-ocular pressure in cases of glaucoma. These measures are vital for eye health. If pressure gets too high, the device communicates to an external system so patient and provider can be alerted.”

Closing the Design Loop

During an FDAnews webinar, Jordan Reynolds and David Wolf, senior managers at Kalypso in San Antonio, Texas, described how IoMT may benefit the medical device industry through enhanced connectivity and data capture.2 One major boon to the medical device industry from the Internet of Medical Things, they noted, is its potential to dramatically reduce cost of poor quality by speeding product fixes and enhancements. A steady flow of accurate and timely data may enable a “closed loop” between product design, development, and the field.

Once in place, IoMT may also allow device software to be updated remotely. Device features could, for example, be enabled remotely by the manufacturer or physician—in real time. Automated monitoring could further track device performance, patient usage, and surgeon usage, while automated reports could improve the reporting of adverse effects.2 Combined, big data and analytics could further lead to competitive market insights and improved regulatory reporting, said Reynolds and Wolf.2

Outcome-Based Payment Models

A greater emphasis across the healthcare industry on keeping patients well is also anticipated, Reynolds and Wolf said during the FDA webinar. With tools to support preventive practices, physicians may be able to better maintain health before illness occurs. “For example, they could use remote devices to check blood pressure, blood components, and urine flow,” Wolf explained to Practical Pain Management. A physician may be able to provide care to a patient who is at home, rather than waiting weeks or months for an office appointment. This benefit may be especially appealing to patients facing immobility.

In terms of tracking patient outcome metrics, analysts at the research and advisory company Gartner of Stamford, Connecticut, reported that chief information and chief medical informatics officers at healthcare delivery organizations “need to produce data confirming superior clinical outcomes, cost of care, and patient satisfaction.”3

A 2017 rule under the Medicare Access and CHIP Reauthorization Act authorizes merit-based incentive payment systems to provide incentives for quality care provided by Medicare Part B.4-6 Although legislators have slowed implementation of quality-based payment, the new paradigm remains squarely on the horizon. Reynolds and Wolf believe that the Internet of Medical Things may be a prerequisite to support the shift from fee-for-service to fee-for-outcome medicine, in which payment for insurance claims is replaced by payment for healthier outcomes among patient populations.2

“Outcome-based reimbursement models are changing the ways clinicians practice medicine,” Wolf said. He envisions IoMT supporting protective action farther upstream in the future. For example, the model may help to correlate a tainted food supply with symptoms of illness.

Protecting Data Points

The myriad of interconnected devices that send data between patients, the cloud, and physicians may present challenges of bandwidth, storage, and cybersecurity.2 In their FDAnews webinar, Reynolds and Wolf sought to debunk the myth that medical device cybersecurity is optional (it is not, they said) and that the FDA tests cybersecurity (it does not, they said). They further affirmed that healthcare delivery organizations are responsible for lowering security risks for devices implemented on their networks.

Wearables and medical devices—whether internally embedded, external, or hospital-managed—have the potential to drown healthcare providers in data points that need to be protected from breaches and inappropriate sharing. A report by Bangalore-based Infoholic Research expects the global medical device security market to reach $28.9 billion by 2023, with cloud security revenue alone reaching $10.47 billion by the same year.7

“The prospect of IT infrastructure overload is very real,” said Dr. Marovino. “As well, we will continue to have problems with data sharing between platforms, with many EMR [electronic medical record] vendors out there having proprietary software that is not capable of sharing with other foreign IT platforms. This leads to the same problems and challenges we have now: data silos with limited inter-operability.”

The Cost of Patient-Centered Healthcare

The Internet of Medical Things may offer unique cost efficiencies and better care, said Dr. Marovino. For example, he foresees “Smart” hospitals and clinics, where patient devices are connected to allow more precise care in the hospital, and multifaceted consoles where patients are able to communicate in real time with their care team, including physicians.

“They will be able to track their progress during their episode of care. Patient monitoring devices will be interconnected with a continuous flow of data describing patient status and from which clinical decisions are made,” he said. “Medication errors should reduce as more precise dosimetry is established with constant monitoring and adjustments. Polypharmacy should also reduce considerably due to better prescription precision and management in general.”

As the Internet of Medical Things shifts the current healthcare focus from tending to the sick to maintaining and enhancing wellness, new opportunities are likely to lend themselves to cost reduction and expedited, transformative patient care.

-Reported by Wendy Lyons Sunshine

Last updated on: December 7, 2017
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