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Running head: HEALTHCARE INFORMATICS RESEARCH AND INNOVATION.

Healthcare Informatics Research and Innovation

Introduction

Innovations continue playing a crucial role in the medical sector. Technological

innovations in medicine have been crucial in medical research, medical procedures, and even

home-based healthcare (Mandl, 2015). It is currently possible for people to assess themselves for

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some given health conditions, and if they establish that their conditions are worse, they can then

call the doctors to look into their conditions. Therefore, innovations in this sector have improved

service delivery and efficiency in this sector.

However, the application of technology in the healthcare sector has not been without

challenges. One of the major challenges includes cybercrimes. The issue of cybersecurity has

threatened the use of innovations in this sector. This is because the occurrence of a cyberattack

not only leads to financial and reputational losses but also leads to exposure of customer's private

information. This has threatened to challenge the advantages of innovations in this field. This has

led to the introduction of medical device cybersecurity. In the center of this is the U.S. Food and

Administration (FDA) authority. This is the body that regulates the introduction and application

of medical devices to try and reduce instances of cyberattacks in the ever-changing technology

world (FDA, 2019). The agency shares this responsibility with cybersecurity researchers,

hospitals, device makers, and other key players in the sector. Devices to be used for medical

purposes require approval from this agency.

Role of Apple watch series 4

This product from Apple has been one of the emerging technologies in the healthcare

sector. It received its approval from the FDA in 2018 to be used as a class II medical device.

Approval by the FDA for medical devices may be either class I, II, or III (Younes, 2018). A

device in class II means that its use involves a relatively higher risk than the class one devices.

However, the agency was clear in the approval that this watch should be used for information

purposes only and not prescriptive purposes.

Goals of the watch

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The watch serves several purposes. These are discussed below:

1. Heart rate notifications

First, it gives the user heart rate notifications. This had the capacity to detect heart rates

that are either unusually high or unusually low. This, therefore, helps the user to identify

conditions that may require further medical evaluation. If the user appears to be inactive for

around ten minutes, and the heart rate is either below 40 bpm or above 120 bpm, the user will be

notified (Younes, 2018). The patients can decide to change the threshold bpm, which warrants

notification or even turn off the notification. The watch notifications capture the time, bpm as

well as the notification dates. All these details can be seen in the user's iPhone Health app.

2. Notification of irregular rhythms

The second objective is to notify users of irregular rhythms. This kind of notification

often detects signs which may indicate irregular rhythms. These rhythms may be indicators of

atrial fibrillation. Although the watch will not detect all AFib cases, it will at least offer the

clients an early indicator of this condition, which will call for further evaluation (Younes, 2018).

FDA has granted this feature De Novo classification for users above 22 years of age who have

not had previous cases of AFib.

This feature is important in the medical sector. This is because atrial fibrillation has been

identified to be among the most predominant arrhythmia globally. Reports by CDC indicate that

between two to six million Americans have this condition.

3. Capturing and recording ECGs

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The third goal of this device is to capture and record ECGs. This is based on the

symptoms which the watch detects and notifies the user, who will then seek further evaluation

from medical experts. These symptoms include skipped or rapid heartbeats. The notification, as

well as the capture time, results, and the symptoms, are sent to the Health app (Su, 2018). These

can be successfully exported to PDF to be shared with a medical expert.

Cardiologists face a major challenge in dealing with heart problems since they only hear

of it from the patients after it has actually occurred. This has been concluded to be ineffective

because solving a health condition that has already occurred and had an impact on the patient is,

most of the time, useless. It is only possible to tell what is happening to the heart if one records

ECG at the time one is experiencing these symptoms. Therefore, this watch provides a solution

to this problem since the irregular patterns are recorded as they occur.

4. Fall detection

The fourth goal of this innovation is to detect falls. If the watch detects a fall, a

notification appears requesting the user to dial emergency services or dismiss the notification. In

instances where the user is unresponsive for about a minute, the app automatically executes an

emergency call and also sends messages to the user’s emergency contacts. These detections are

also recorded in the Health app.

Falls have been identified to be among the main causes of injuries globally. These often

follow some particular patterns like slipping backward or tipping forward. Each fall pattern

comes along with given body motion and movement of the hands. The watch, therefore, uses its

gyroscope and accelerometer to detect instances where the user falls (Su, 2018). Detection of the

fall, therefore, happens due to the capability of the watch to analyze the wrist trajectory as well

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as the resultant acceleration.

5. Medical ID

The last goal of this innovation is to allow the emergency room clinicians or first

responders to gain access to critical information concerning the patient from his/her iPhone’s

lock screen without asking for a passcode and the same time without compromising the privacy

of the patient (Apple, 2020). By setting medical IDs on the iPhone's health app, it will be

possible for patients to list critical information such as conditions, allergies, medications,

emergency contacts, and organ donor preferences.

Security enhancements

The device is designed with a privacy mind to prevent a breach of the user's privacy.

Once a user locks his/her iPhone using a passcode, face, or even touch ID, encryption of their

health data in the Health app takes place in the device (Apple, 2020). If the user opts to sync

their health information with iCloud, the data will be encrypted when being moved and even at

rest.

Healthcare settings

The watch has capabilities which enable it to conduct an ECG. Its back has electrodes

that are made into digital crowns. The user is then required to touch the digital crown for half a

minute. This leads to the creation of a closed-loop, which then generates ECG waveforms. The

information gathered enables not only the capturing of the heart rate but also shows the rhythm.

Education concerning how to use the watch is available on the company’s website. Here,

they elaborate on how to utilize the capability of the watch as well as interpret the findings. This

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is important since it ensures that the users understand the meaning of some results and the

severity of their conditions.

For instance, after taking the ECG, the findings need to be understood by the users. The

app enables the user to differentiate between sinus rhythm and atrial fibrillation. However, it

does not have the capacity to detect some critical conditions such as heart attacks. Once the user

takes this reading, the app will check for the two factors (Apple, 2020). If the heart rate is under

40 bpm or beyond 120 bpm, it will be impossible for the app to check for AFib. However, it will

note the heartbeat as well as save the ECG recording.

Conclusion

In a nutshell, technological advancements in the medical sector have served to transform

it both in terms of capacity and efficiency. Besides, these innovations have helped to enhance

diagnosis for various conditions. For instance, the use of the Apple watches 4 series, as seen in

this paper leads to the detection of several conditions that may prompt the user to seek medical

interventions. Although the watch may only serve notification purposes, it plays a crucial role

since it lays a foundation for further evaluation of the conditions.

However, as these innovations continue increasing in terms of numbers and capabilities,

it is important to keep the issue of cybersecurity in mind. This will be crucial in ensuring that

they do not lead to a violation of customer privacy laws. This may be through the adoption of

various cybersecurity measures, such as the use of encryption, as seen in this paper.

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References

Mandl, K. D., Mandel, J. C., & Kohane, I. S. (2015). Driving innovation in health systems

through an apps-based information economy. Cell systems, 1(1), 8-13.

FDA. (2019). Medical Device Cybersecurity: What You Need to Know.

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Younes, A. (2018). Apple Watch Series 4 Receives FDA Approval as a Class II Medical Device.

Cardiology now.

Apple. (2020). Apple watches. Helping your patients identify early warning signs.

Su, J. (2018). Apple Watch 4 is now an FDA class 2 medical device: Detects Falls, Irregular

Heart Rhythm.