Guest Column | June 13, 2019

Ensuring Data Integrity Of Medical Devices: IT Challenges And Solutions

By Kayla Matthews, Productivity Bytes

Scientist Data

Data integrity relates to maintaining data to ensure quality and consistency throughout the life cycle of the respective information. Data integrity applies to many industries and use cases, but it's exceptionally important in connection with medical devices.

Insufficient Backup Practices Compromise Data Integrity

Many of the leading medical devices have automatic backups that transfer data to the cloud on a set schedule. But, in the case of any data-collecting medical device, it's essential to settle on a backup routine and method that meets the needs of the organization and the patient using the device. Challenges arise if data does not get gathered at all or if errors occur that cause the unintentional overwriting of necessary data.

Failing to have backed-up data could lead to less effective patient care strategies, especially if the reason for using the medical device is to gauge how a person's condition changes over time.

A backup that performs as expected is a crucial part of promoting data integrity. One practical solution for solving the data backup challenges related to medical device data integrity is to carry out periodic checks of backup settings and the collected data to verify effectiveness. That could happen during a patient's office visit. Or, if the medical device is part of a healthcare facility's inventory, the assessments might occur under the oversight of the IT team.

Audit Preparation Relates To Data Integrity Proactiveness

Another obstacle to overcome, associated with medical devices and data integrity, is the potential for regulatory audits. In December 2018, the U.S. Food and Drug Administration (FDA) issued new guidelines for data integrity related to regulatory reviews of pharmaceutical companies. A statement about the matter indicated that the organization had uncovered previous data integrity issues and found they could mask drug-related problems.

When drug companies or medical device manufacturers stand behind their data integrity practices, it's easier for them to get ready for audits and feel confident about the possibility of facing them. The majority of healthcare chief information officers (CIOs) lack trust in the integrity of their data, a study shows, and three-quarters of those polled in it want to invest in data integrity improvements.

It can be difficult to know where to start with such an undertaking. Medical device makers of all sizes and types need to trust their data's integrity. One way to make progress is to partner with a company that's familiar with things covered during audits, like good documentation practices and error correction.

Besides offering training to help healthcare entities prepare for data integrity audits, many provide remediation recommendations that address any faults uncovered in previous assessments. Moreover, if clients of such companies want assistance with implementing those remediation plans, experienced companies can help.

A lack of preparedness for audits in the healthcare industry can bring about a host of related trouble. This ranges from reductions in hospital quality ratings, to high turnover rates that happen when employees decide working at healthcare facilities that aren't well-prepared for audits could reflect poorly on their career aspirations. Reoccurring poor audit results could also cause a device maker or hospital to get shut down or put on probation.

Healthcare Workers Play Crucial Roles In Supporting Data Integrity

Cybersecurity breaches negatively affect data integrity efforts, and the healthcare industry at large is a prime target for hackers. Protenus studied the number of healthcare data breaches occurring in 2017 and 2018 and found that the number in 2018 nearly tripled the 2017 amount and totaled 15 million compromised records. But the good news is that when organizations take data integrity seriously, the risk for cyberattacks goes down.

Health care workers substantially assist in data integrity efforts for medical devices. But a challenging reality is that not understanding or adhering to best practices for handling medical device data could make breaches more likely to happen. For example, 63 percent of data breaches exploited a weak password. Also, people could consider the possibility of healthcare workers using medical devices that come with default passwords and never changing them.

Cybersecurity experts also warn of the possibility of hackers infiltrating embedded medical devices such as pacemakers and insulin pumps. The consequences could harm patients in the worst scenarios and at best, give healthcare providers inaccurate readings.

Whether regarding passwords or another safeguard for data and network security, the information that healthcare workers receive about the part they play in data integrity should ideally feature easy-to-follow steps. Regularly occurring training sessions are also essential, especially as workers start using new devices, or the devices they know well get substantial updates through software updates.

People Power To Address Shortcomings

A company's culture must align with data integrity practices and address everyone in the organization who handles data, from the IT team leaders to the student nurses. When that happens, people will recognize that data integrity is a team effort and collective responsibility.

No company or person is perfect when it comes to upholding data integrity. That's why it's essential for relevant parties to work together and ensure that as their medical device usage grows, so does their commitment to outstanding data integrity leadership.

About The Author

Kayla Matthews is a MedTech writer whose work has appeared on HIT Consultant, Medical Economics and HITECH Answers, among other industry publications. To read more from Kayla, please connect with her on LinkedIn, or visit her personal tech blog at