Data compliance assurance in healthcare and life sciences

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Amidst increasing regulatory scrutiny, the healthcare and life sciences industry endures to face unprecedented challenges.

Ever evolving needs of existing and emerging customers are driving enterprises to re-examine their approach towards data compliance.

According to Gartner, “Healthcare providers are experiencing unprecedented levels of disruption. Sixty-three percent of healthcare providers have faced severe disruptions due to reasons including internal organizational changes, cost pressure, regulation and compliance, funding or shifting consumer demands. With all the changes in the healthcare industry, only fit organizations thrive — and fragile organizations get left behind.”

With increased emphasis on innovative technologies, heightened transparency expectations, globalization, and alliances & partnerships, enterprises are facing data compliance challenges in ensuring a strategic balance between compliance risk and value.

Challenges affecting data compliance in healthcare and life sciences

To align with the growing regulatory restrictions put forth by the establishments, healthcare and life sciences industries are moving forward with innovative initiatives.

However, they are finding it difficult to keep in pace with the faster evolving standards.

The major challenges that the healthcare and life sciences organizations face based on the growing data compliance requirements are:

  • Complex data compliance regulations that are difficult to manage and implement.
  • Lack of regulatory process automation tools that can simplify repetitive regulatory operations and save time.
  • Inability to set up time-based or triggered scans to check continuous data compliance so that every change is compliance-checked before release.
  • Lack of real-time monitoring tools to get full visibility of compliance health that lets you instantly check for any data compliance violations.
  • Inability to manage all the data compliance requirements with simple configurable rules that does not require any coding.

Healthcare and life sciences organizations can overcome these data compliance challenges with the use of advanced tools and a better view on implementation of regulations.

How to value data compliance in healthcare and life sciences

Healthcare and life sciences segments such as biotech & pharma, contract research organizations, clinical laboratory, and medical devices & diagnostic organizations must concoct for and manage a new surge of regulatory review and enforcement actions.

Failing to conform with changing regulations can have grave consequences, including penalties, criminal trials, and disentitlements.

According to a research study from Deloitte, “There are clear opportunities for compliance functions to extract more value from data by improving IT infrastructure and systems and partnering more effectively with the business. Life sciences companies need to set out a clear vision to successfully implement data analytics, defining an IT infrastructure strategy that centers on the needs of the compliance system and delivering an enterprise-wide view of compliance risk.”

Data is key in healthcare and life sciences transactions, and it is imperative to value data compliance in this industry.

Three factors that gauge the core of the value of data are –

  1. The data associated with material liabilities.
  2. The contractual terms that the seller has made with the buyer to restrict the use or disclosure of the data.
  3. The laws that restrict the transfer or anticipated use of the data.

Buyers of healthcare related data must carefully verify and validate the compliance and other legal aspects.

Healthcare and life sciences organizations need stronger security of data

As the world begins to realize the unlimited potential of technology to improve lives, healthcare and life sciences organizations must reassess information security policies while adopting emerging technologies to enhance the efficiency and quality.

The constant slew of data breaches in the healthcare and life sciences industry has proven that many healthcare delivery organization’s (HDOs) current controls and security practices are inadequate.

According to Zafar Chaudry, research director at Gartner, “Identifying risks and protecting electronic health information can be challenging. HDOs house personal health information and payment information, and all are lucrative targets for hackers, as well as malicious or curious insiders. Most HDO employees, however, want to help people, not become technologists, and may view information security protections as obstacles to delivering healthcare.

Enterprises need to sustain a security program that has visibility in the risk status and its current security implementations.

It is recommended for healthcare industries to track security metrics in areas such as data protection, 3rd party risk management, security governance, incident & detection preparedness, and technical hardening and testing.

Healthcare and life sciences organizations manage highly sensitive data and it is pivotal to integrate the security considerations as early as possible to minimize downside risk.

While the need for stronger security is mandatory, assuring data compliance in healthcare and life sciences will help solve many perilous issues.

Assuring data compliance in healthcare and life sciences

Data compliance was traditionally viewed as a mere insurance policy against risk and thus received low attention. This perception is no longer sustainable.

Data compliance in healthcare and life sciences must be viewed as a source of customer differentiation and competitive advantage.

The kind of approach that a healthcare and life sciences organization takes towards innovation should also be taken to assure data compliance.

For the future sustainability of the healthcare and life sciences industry, a conservative approach to data compliance will not suffice.

Organizations have to mitigate emerging and new compliance risks whilst being efficient, effective, and future-proofed to support current compliance requirements.

According to Forrester, “New privacy rules are popping up all over the world. Increasingly, security and risk (S&R) and privacy professionals believe that maintaining compliance with global privacy regulations is one of their top challenges.”

It is vital for healthcare and life sciences organizations to assure data compliance but in the process of achieving the goal, it comes with a set of challenges.

Unravelling complexity of data compliance assurance

The complexity of managing data compliance assurance can well be achieved by developing an ethics driven culture, through effective governance and leadership.

According to Gartner, “Life science CIOs must proceed with care to realize the benefits of real-world data in the face of new data privacy regulations and a maturing data vendor ecosystem.”

A paradigm shift is visible in the healthcare and life sciences industry. With the proliferation of emerging technologies such as Internet of Things (IoT) and Big Data, emphasis has been amplified on customer-centricity.

A modern approach to data compliance management brings together all patient-centric initiatives under a roof and eases the complexity.

The keystone for building a competent healthcare ecology is by sustaining patient trust and until data compliance and security are assured, it’s an uphill task for any organization to improve the healthcare and life sciences environment.

Closing thoughts

The Healthcare & Life Sciences industry needs to adhere to various rules & regulations under 21 CFR Part 11, GxP Compliance, & Good Automated Manufacturing Practice (GAMP).

This necessitates adoption of digital technologies, big data analytics & BI, compliance with a wide regulatory landscape, legacy modernization, transforming processes & systems, improving IT efficiencies, and ensuring functional efficiency, performance, security, and privacy of applications, data, & devices.

Cigniti offers software testing solutions for diverse life science and healthcare players such as hospitals, pharmaceutical companies, healthcare services, clinical labs, diagnostic centers, third-party administrators (TPA), payers, medical equipment manufacturers, healthcare ISVs, and research organizations.

We provide end-to-end Advisory & Transformation services, Test Automation, and Performance, Functional, & Security Testing solutions with a strong emphasis on regulations, compliance, quality, and more.

Talk to our healthcare and life sciences experts to know more about assuring data compliance in healthcare and life sciences.

Author

  • Cigniti is a Global Leader in Independent Quality Engineering & Software Testing Services with offices in US, UK, India, Australia, and Canada.

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