Medical Devices Begin Learning How to Talk

Edward P. Ambinder, MD

OBM: It’s often said that computer interoperability is not yet sufficient for the practice of oncology. Do you agree with this?

Edward P. Ambinder, MD, clinical professor of medicine at the Icahn School of Medicine at Mount Sinai, serves as chair of the ASCO Health Information Technology Work Group. He has a special interest in improving the interoperability of computer technology to facilitate the sharing and security of patient records for the purposes of furthering patient-centric, coordinated, and value-based care. He spoke with Oncology Business Management™ recently about advances that are making this possible.Ambinder: Gathering electronic medical data and planning treatment for a patient should really be no different from planning a trip on the Internet. What the Internet permits is for you to go to a travel site, identify yourself, define your preferences, and have your credit card accepted. You may want a flight somewhere, so you are connected to a database with flight information from every airline and you put in what you want. The computer knows that you are going to arrive at a given city, so it’ll ask whether you need to be met by a taxi or limo and help you to arrange that. You may also need a hotel room, so you’re connected to a site that has all the information about hotel rooms in that city.

What’s the solution to the problem of siloed medical data?

So, basically, the problem is the way the healthcare system works with a patient’s data. Their data is on multiple different computer sites, and it’s impossible, really impossible, for patients to say “I want to have all my medical data.” And if they have laboratory tests, “I want to have access to data from the commercial laboratory, or the hospital laboratory, or my provider’s laboratory.” We’ve made it very difficult because, in the past, all of these organizations that controlled the data felt they had to control it because it kept the patient with them. What happened with governmental oversight of care and the different regulations on how doctors get reimbursed is that we were given a significant amount of money to use specialized electronic health records (EHRs) that could do everything except interoperate and simplify the sharing of data.We have international data and interoperability standards now that define every piece of medical information, every medical report, whether it’s a lab report or a PET scan report or a discharge summary. Health Level Seven International (HL7) has created architecture for defining almost every type of medical report we use. One is a consolidated Clinical Document Architecture (C-CDA), which summarizes all of your medical information in a machine-readable and human readable report. I sit on a committee at ASCO where we oversee health IT activities. We have created a CDA document to summarize the complete cancer journey of a patient who is being treated for colon cancer or breast cancer: the ASCO Clinical Oncology Treatment Plan and Summary. And we recently created a companion C-CDA document, called ASCO’s Survivorship Care Plan (SCP), to deal with survivorship care of any cancer type. In this document, we capture all of the basic clinical information necessary to understand what has happened to a particular patient during their cancer journey and how they should be monitored afterwards.

The Commission on Cancer has mandated that all cancer patients will need to have an SCP given to them that could be made available to other providers and caregivers or used for state registry reporting, rapid learning systems like ASCO’s CancerLinQ, or other research purposes. And once that’s arranged, then you have an efficient system where a patient’s primary care doctor creates a report which we call a Continuity of Care Document (CCD), a type of C-CDA, which can be sent electronically to any consulting specialist, like an oncologist, with all of the medical data that a general internist would want on the patient.

HL7 is also developing a more nimble, less expensive, more internet resource friendly, and granular architecture that can handle individual data elements, making data more available to research and discovery. It also works with existing C-CDA documents and is much easier for the technologically-shy to work with. It is known as Fast Healthcare Interoperability Resources (FHIR) that will, in the near future, become the leading data standard and interoperability enabler. The oncologist would have tools that combine FHIR and application programming interfaces (APIs). Basically, these pick up data from one computer or app and move them to another app or computer, or to API-enabled EHRs.

Those data can be brought to a health information technology app and can do wonderful things that an EHR can’t do. So, for example, if you have a patient who has genomic data on the computer of a genomic company, that particular information can be accessed by an app API and incorporated directly into an API-enabled EHR database, if everyone agrees to follow the rules of the system.

Do you believe it’s possible to protect patient information to the same degree as financial information is currently protected?

Do you see similar conveniences emerging in the management of patient data?

For this to work, the EHR has to be customized for the needs of cancer and to make sure that the data that’s collected is up-to-date in view of the dramatically increasing amount of data that we’re going to need to really monitor and measure a human’s “omic” data. This will overwhelm the comprehension of oncologists and their EHRs that can both barely keep up with the “classic” type of medical information that we used to scribble in our paper chart. So, we are going to be able to understand what technology can do and how standards can enable interoperability to become a seamless method of connecting anyone who has the right to receive medical information. That’s going to make a huge difference in saving time oncologists spend re-entering data. It’ll also save patients from having to fill out their medical history on paper every time they go to a new doctor.You use the same standards. In other words, if I go to the financial planning site Mint, I have to give them my usernames and passwords, which they use to go to financial organizations to get financial information from checking and brokerage accounts with particular banks or Wall Street firms. And then they take that data and they will store it, and they will consolidate all of the different financial information. Then they will give me a picture of how everything fits together. There are tools on the Internet that can deal with anything related to the Health Insurance Portability and Accountability Act (HIPAA), anything related to identification of a person, provider, or proper authorization. I have no doubts that, with current internet standards and tools, the movement of encrypted medical data can be done in a safe and secure way.What Apple has done with mobile computing and apps for healthcare is amazing. They have the iPhone, which has frameworks, such as a Healthkit that stores medical device data, vital signs, and other health measurements. The data are controlled by the patient. The patient can give that data to anybody they want. They can give it to a doctor, a hospital, or a health system. It’s encrypted, and it’s kept in firmware on the medical device, so it doesn’t go to the “cloud.”

ResearchKit is an open-source framework that is primarily intended to make it cheaper and easier for researchers to rapidly recruit large numbers of patients, educate them about a study, obtain their consent, help collect the data, and connect them to providers involved in the study or in special circumstances with other participants in the study. CareKit is an open source framework for health apps. It has core modules that include a way to display care plans, a symptom and measurement tracker for monitoring symptoms and tracking objective measurements, health tips, a means of visualizing trends, and ways to engage care teams and family members as partners in the health journey.

Once this information is loaded into your iPhone, what then?

Apple is putting into their latest operating system (iOS10), the ability to capture a C-CDA medical document, which any EHR can make available to us, or a CCD, which the primary care doctors create based on their evaluations of the patient. That document can be placed on an iPod or an iPhone. It’s on the hardware—in the firmware—and, again, it’s totally controlled by the patient and nobody can get to it, not even Apple. The patient can share these interoperable documents with most modern provider and hospital EHRs.They’re creating a system where you can be anywhere in the world where there’s a 911-type system, and if you’re in trouble and you have your medical summary on your phone, you can press the button, on your watch or iPhone, invoke the SOS app, and connect directly to the 911-type of that location. The phone knows where you are. It immediately opens up the audio channel and the video channel, so that the person who is at the 911 site can receive audio and video. Since your medical record is on the phone, it can be sent to the emergency medical people who are responding.

The Apple watch and iPhone could automatically monitor your vital signs, and up to two people who were chosen before the emergency can be contacted if you’re in trouble. They will be alerted and put in constant audio and visual contact with the person at the 911 number. The EMT who is getting your medical information could have received a CCD or a CDA document, or both, or an abridged medical history that is entered by the device’s owner for those who do not have access to these standardized technical documents. They also have actionable information about you when you’re in trouble. Knowing Apple, I would not be surprised to see the SOS app being able to detect if a person falls and undergoes a period of unconsciousness, which would trigger a 911 call but also permit the owner of the device to cancel the call within 15 seconds if it was an error.

So, to me, this is the way I want to practice medicine. I want my engaged patients to be protected. I want my patients to really be able to access any of their medical information. We’ll no longer be in a world where we have silos of information that nobody can use. Once you break the silos, it’s amazing how much more efficient, how much safer, and how much more effective, enjoyable, up to date, and customizable our EHRs could be. And that’s where things are going over the next several years.

We really do have the capability of having what everybody wants: a value-based system that’s efficient, where the computer works for you and you don’t work for the computer. Today, the doctors are frustrated because the EHRs don’t have these functionalities. They’re not designed to help the doctor get information especially for the cancer patient, and it becomes a nightmare where when doctors are putting in one to two extra hours every night to deal with inputting and documenting the this data. They take that time away from seeing the patient. It’s a system that can’t survive. In my mind, I really think that’s the way we’re going. I see how the internet works for everybody else. The beauty of it is, it works. You don’t have to think about it, you just do it, and that’s what we want to be able to do with healthcare data. With the existing tools, you can have HIPAA-compliant secure data. And if you really want to make the data as secure as possible, you do what Apple is doing with patients’ records.