Chapter 4

Chapter 4: Some grave concerns

Now, Let’s head ahead a few years down the road when this system has already been firmly established and the sensors are everywhere. There, a very curious child, (stating the obvious, all children are curious) is really concerned about the safety of those ingestible sensors, and so she asks her mom about it.

The child: Mom, do we know if these ingestible sensors are safe?

Mom: Yes, they are, my child.

The child: But how? How do we know it’s safe?

Mom: I will give you a research paper to read on it? Do you want to read about it?

The child: But how am I going to understand it? I am only 5.

Mom: Well, then you won’t understand what I will be saying about its safety performance as well. Come to me after you have grown more and I will tell you about it. Okay?

The child is dissatisfied, but she accepts her mother’s answer. Few years later, she is working with some friends on a project for her high school, and so now, they are actually discussing about the safety performance of these ingestible sensors.

Child 1: Hey, I asked my mom about this when I was a kid, and she didn’t really answer me.

Child 2: Don’t worry. I asked my father about it when I was a kid, and I understood nothing he said. Then, I went and read a research paper and I understood everything.

Child 3: How come you understood it? You were only 5 then.

Child 2: I time travelled to read about it.

Child 1: Huh!!!

Child 3: Huh!!!!!

Child 2: Don’t worry, anyone can time travel nowadays.

Child 3: So, what do you remember from the paper?

Child 1: So, how do we know it’s safe?

Child 2: The bottom line is that all of the sensors have passed the safety performance experiments, so that’s why they are safe.

Child 1: But what are those tests?

Child 2: They have to perform different tests on the sensors – chemical safety experiments, toxicology safety experiments, mechanical safety experiments, and electrical safety experiments. For the mechanical, electrical and toxicology safety experiments, the tests are done on canines, and after the tests, gross necropsy is performed on them to see if anything has changed in the canines. (5)

Child 3: What does it mean – gross necropsy?

Child 1: It means killing the animal and seeing it’s inside.

Child 3: Oh, no. That’s horrible. (looks like she is going to cry, but doesn’t)

Child 1: What are those different tests for?

Child 2: Let me see. Well, the chemical safety experiments are done to see if the chemicals used in the sensor are well below the allowed amount of intake and they were well below the allowed amount. Similarly, the toxicology safety requirements are to check if there was any sensor-related toxicity, and there was none. (5)

Child 2: Mechanical safety was to see if the sensor caused any luminal injury in the gastric channel, in intestines, and there was no evidence of that at all. Perfectly mechanical safe. Lastly, electrical safety was measured to see if there were any chemical burns due to the electric voltage and if there was stimulation of any cardiac or gastrointestinal tissue due to the electrodes of the sensor, and it was proved again, there were no risks to be seen at all.

Child 1: Today I am going to tell my mom now that I know whey these sensors are safe.

Child 2: So, every kind of devices that are ingestible has to pass all of these safety procedures. If not, it’s not approved by FDA at all.

Child 3: And also in the same test, I think they proved the reliability of these edible sensors. These sensors were taken by 412 patients and they were able to detect ingest 99.1 % of the time. And “the sensors correctly identified the type and dose of the drug taken 100 % of the time for all 20, 993 ingestions during the trial”. Similarly, there was no recorded false positives, and zero evidence of serious or unanticipated adverse event. (12)

Child 1: So, they had to prove both their safety and reliability before bringing it to the market.

Child 2: Of course, they had to. Otherwise they are going to kill everyone.

Child 3: They killed the dogs anyway.

[Meanwhile not far from that place, another kid was curious about another aspect of this Helius care system. So, he asked his mom.]

The last child: Mom, aren’t there any privacy issues related to Helius care system.

Mom: Shut up, kid. What do you know about privacy? You are only 4.

So, in order to talk about privacy issues related this Helius care system, we are going to the red carpet of 2014 for the victims of privacy issues related to electronic health records, where April, a reporter is asking questions or interviewing those victims

[Enters in a long coat, the doctor of Howard University]

April: So, what happened doctor? How are you the victim of the privacy issues related to patient data in electronic health records?

Doctor: The information of 34, 000 patients were compromised from a laptop, which included the names, addresses and social security numbers, and diagnosis related information of the patients. (13)

April: So, you were a victim of data theft? But how are you the victim though? Your patients are probably the actual victims of the theft?

Doctor: Yes, but in a way this creates a distrust among the patients, so which is a loss for us as well, because now patients might lie or give us wrong information about some other things.

April: Thank you, sir. Please take your photo there in front of the photo graphers. (the doctor leaves)

Suddenly 5 million people arrive. April is shocked to see so many people. Before April can ask them anything, they ran over her, shouting together, “Our names, social security numbers, and clinical notes and test results were also hacked. We are the victims. We are the victims.” (13) After they are gone, April gets up, and dusts herself off.

April: (to the camera) All the viewers out there, you can see, so many people have become the victims of security breach in their medical records. Privacies of so many people have been compromised. It makes us ask the question, “Is this new electronic or mobile health record worth it?” Here is the main cardiologist. Let’s see what he has to say about privacy.

The cardiologist: This is a completely overblown issue, and consumers don’t mind sharing data if it’s done in the right context. “So I don’t think anyone cares whether someone can hack into how many steps they’ve taken or what their weight was. What they really want is to be healthier. I think if we’re going to move connected health and digital health forward, we have to get across this. I’ll be honest with you it’s the 50 and up that really care about this but you have 20-year-olds posting pictures on Facebook, they don’t care about privacy. Neither do 30-year-olds and 40-year-olds.” (10) 

The cardiologist goes to the photo area, where there are flashes everywhere and his photos are being taken. Meanwhile Proteus Digital Health Chief Product Officer David O’Reilly arrives in his suit.

April: What do you think about privacy issues? Do you think they are completely overblown like the former guy?

O’Reilly: Not at all. I think they are important and should be embraced by us. But we need to face the reality and embrace it. There might be times we might violate the trust and have to pay for it, but we must all face it. (10)

April: Tell us something more about Proteus Digital Health’s Helius and how safe it is?

O’Reilly: What I can say is that, the data that you have, you can chose to share it with whoever you want. Only the person who you want to see your data, like your daughter can see the data, so you have a good deal of privacy while using it. We comply with the privacy regulations in the US and EU, and we make sure the data are safe and secure. (14) That's all I can say now.

April: Thank you, sir. (O’Reilly leaves. Before she can say anything, a lady arrives)

The lady: This is very very unfair.

April: What is unfair, ma’am?

The lady: This. This privacy breach.

April: What’s your story, ma’am?

The lady: Why does a dentist have to have access to my reproductive health history? You know, this is unfair. They shouldn’t have access to the information if they do not need to know. (15) You know, I got shocked when he started talking about my reproductive health stuff… I mean….

April: I suppose, it’s good if you like him. (before the lady can say anything) Or maybe not, the photography booth is over there, ma’am.

April: So, that’s all for now. We can definitely see privacy issues in these type of technology where there is sharing of patient data. This issue really needs to be addressed very strongly in the upcoming years. We will take a short break now, before we talk with more victims.