Custom Software Solutions for Managing Healthcare Compliance and Regulation

Custom Software Solutions

For Managing Healthcare Compliance And Regulation

Introduction

Healthcare compliance is simply the obedience to laws, regulations and guidelines that govern healthcare operations. These regulations — including HIPAA, GDPR and HITECH — exist to protect patient privacy, ensure the security of health information, and preserve the integrity of healthcare delivery. Without compliance, patient data is vulnerable or stolen, the public distrusts healthcare organizations, and these institutions cannot operate efficiently.
Compliance, or a lack thereof, permeates every nook and cranny of healthcare at both a national and an individual provider level. Non-compliance can mean harsh penalties such as fines, litigation, loss of accreditation, and reputational damage to the organization. Moreover, compliance is an ever-changing landscape that requires continual updating of liberties and requirements for healthcare organizations and providers. Therefore, the importance of effective compliance management cannot be understated, as it is necessary for avoiding the severe risks associated with organizational failure.
A custom-built software solution provides you with control over compliance and regulatory requirements, which may not be available if you choose an off-the-shelf system. This is because custom-built solutions can be designed to capture your exact compliance requirements and allow you actually to manage them better. These solutions can be designed to streamline your compliance process, automate routine tasks, provide real-time monitoring and reporting, and otherwise make you a more efficient and effective organization. If done properly, it will give you more time to spend on your patients while still giving you and your customers a robust compliance system that is easy to use and manage and that actually supports your core mission of patient care.

Understanding healthcare compliance requirements

Key regulations in healthcare

Healthcare compliance is managed through several ethical rules, which are utilized to secure patients' personal information and keep healthcare services in good order. Among others, they may include:

HIPAA (Health Insurance Portability and Accountability Act): The US Health Insurance Portability and Accountability Act establishes a national standard for protecting the privacy and security of health information. It covers the health care provided by doctors, nurses, dentists, psychologists, and other medical personnel working in hospitals, clinics, meaningful-use settings, and other facilities that transmit health information in electronic form.
GDPR (General Data Protection Regulation): Applicable in the European Union, GDPR is a sweeping body of data protection laws, including restrictions in obtaining patient consent for storing and handling data, stringent conditions of data security, and the ability to port personal data, with applicable penalties that can reach up to 20 million Euro. The regulation applies to any organization dealing with the collection of personal data of EU citizens.
HITECH (Health Information Technology for Economic and Clinical Health Act): US law enacting legislation to promote the use and ‘meaningful use’ of health information technology, to strengthen the privacy and security protection of health information, and to stimulate the adoption of electronic health records.
21st Century Cures Act: US law that promotes the development of new medical products and spurs research while creating new rules for information blocking and better electronic access to patient data.
US Food and Drug Administration regulations: For software that is a class III medical device, the US Food and Drug Administration (i.e., the agency responsible for regulating drug and food safety in the US) mandates compliance with regulations that ensure the ‘safety and effectiveness’ of software used in a healthcare setting.

Common Compliance Challenges

Healthcare organizations face several challenges in maintaining compliance with these regulations, including:

Data security: This is one of the biggest challenges when it comes to machine learning: your patients’ data could potentially be at risk, meaning that some form of security, such as encryption, secure authentication and regular vulnerability assessments, is undoubtedly needed.
Patient Privacy: Managing consent, controlling access to health information, and ensuring that data is used for the purposes for which it is collected become both a compliance obligation and a moving target as patients, insurers, researchers, and other parties carve out rights to aggregate and use data in new ways.
Record-Keeping: Keeping an accurate record of all interactions with research subjects and their responses to treatments and other interventions is required and can be cumbersome. Institutions must maintain records of all contacts and treatments of research subjects and their responses to interventions and compliance activities in a manner that facilitates easy access and accurate storage.
Changing regulatory requirements: Organizations need to keep up to date with new regulations and implement changes accordingly. Organizations need to think about how they comply with the newly requested procedures that are continuously implemented.
Training and awareness: Making sure all employees know their compliance responsibilities. Keep staff aware of their obligations and mindful that compliance is part of their daily operations by implementing an ongoing training and awareness programme.

The role of custom software in compliance management

Tailored solutions for specific compliance needs

That is where custom program solutions play a significant role in the compliance ecosystem of healthcare organizations. In contrast to off-the-shelf software that offers standard features for general use, a custom solution has the ability to work in alignment with an organization’s distinctive regulatory environment and operational processes. With the involvement of compliance experts and other stakeholders in the planning process, the developer can create a software module that specifically addresses the compliance needs of a specific organization. For instance, a custom solution can be developed for using medical billing software, and the developer can design appropriate features such as encryption, audit trails, and role-based access controls so that the organization can comply with the requirements of regulations such as the Health Insurance Portability and Accountability Act (HIPAA), the General Data Protection Regulation (GDPR), and Health Information Technology for Economic and Clinical Health Act (HITECH). This makes it easier for healthcare organizations to embrace regulatory standards and meet their compliance requirements accurately. Since tailored solutions are built around the organization’s specific needs, they can be adapted according to an organization’s changing requirements and regulatory changes.

Automation of compliance processes

Automating compliance-related tasks with custom software will likely be among the greatest benefits achieved through such systems. The key advantages will derive from the fact that compliance tasks are repetitive administrative tasks, including audits, reporting, and documentation, all of which can be automated. Furthermore, these tasks – especially if done manually – are generally poorly executed and can be prone to human error. Automating the tasks will minimize the risk of human error by enabling repetitive standardized tasks to be performed every time the same activities are carried out. For example, a piece of custom software could automatically generate compliance reports, track documentation, and schedule audits as needed to ensure that all required activities are executed at the time stipulated by the relevant regulations. Automation will not only enable organizations to efficiently carry out compliance-related activities but also to save valuable time and decrease administrative burdens for staff, as computerized systems increasingly enable workers to spend less time on routine and manual tasks and more time on more strategic endeavors. Furthermore, an automated compliance system will ensure that all relevant compliance activities are never overlooked, eliminating any likelihood of non-compliance.

Real-time monitoring and alerts

Further, real-time monitoring and real-time alerts are additional critical features built into custom compliance management software. These enable ongoing oversight and enable the organization to immediately address issues as and when they occur. Programs can be set up to track key activities related to compliance and real-time performance of the system, with immediate alerts when certain activities or alert patterns are detected. For instance, a real-time monitoring program might detect unauthorized access to patient’s personal data, such as their medical records, in a hospital database. Software is then able to immediately alert administrators of the situation and allow immediate recourse to remedy the situation. The immediate response to vital concerns enables a healthcare organization to address issues of concern quickly to ensure patient data is never jeopardized. Real-time monitoring also assists in ensuring organizations respond to changes in regulatory requirements in real-time and are in compliance with ongoing changing regulatory rules.

Benefits of custom software for healthcare compliance

Enhanced compliance accuracy

The usage of custom software enhances accuracy in compliance due to reduced human involvement and greater consistency in complying with regulatory standards. Typically, manual compliance procedures tend to expose failing points, which human operators might overlook. For instance, navigating through regulations requiring data entry, compliance management, reporting, follow-ups, and outcomes can expose errors such as incorrect data entry, missing compliance deadlines or reporting, non-checks, or missing records. Similar examples can be medical records, outdated patient follow-ups, non-checks for drug interactions, and incorrect applications of specific medical tests for a particular condition. The use of custom software minimizes human errors by automating the repetitive compliance process and enhancing consistency in complying with regulatory standards. It can validate records based on prior analysis and consistency under regulatory standards, compute accurate reports, and warn or notify appropriate individuals about potential problems that would otherwise lead to serious compliance issues for the organization or staff. Thus, using custom software will help healthcare organizations attain greater accuracy and reliability in complying with regulatory standards with minimal risk of overlooking compliance requirements and guidelines.

Cost-efficiency and resource optimization

Custom software can also achieve significant cost savings and resource utilization advantages by automating compliance processes and functions such as reporting, documentation, and auditing. This not only reduces the need for human intervention and administrative overhead – thereby reducing labor costs and freeing up resources for higher-value tasks – but also lowers the cost of risk by reducing the likelihood and severity of non-compliance penalties that could be imposed for failing to meet regulatory requirements. In the longer term, custom software can help to maintain compliance with regulations, ultimately resulting in reduced operational costs and enhanced resource allocation.

Improved patient trust and organizational reputation

Custom software built to keep compliance consistently high can help bolster patient confidence and enhance an organization’s reputation. Compliance with HIPAA and GDPR requirements shows the organization’s commitment to respecting and protecting patient data privacy so patients know their most intimate personal and health issues are maintained with the highest level of security. Suppose a healthcare organization shows year after year that they have a solid record of following the regulatory rules. In that case, patients will gain confidence in the organization and be more likely to remain loyal, maintaining preferences at the top of the patients’ list. A strong reputation will benefit the organization by setting its public image apart from its competitors. Investing in custom software that enables your company to maintain compliance can not only provide a tool to avoid regulatory fines but also keep your organization in a position to maintain and build a positive reputation in the marketplace.

Conclusion

To summarize, custom coding solutions help overcome the shortcomings of generic systems in the healthcare compliance and regulation big picture by presenting the industry with distinctive solutions. The solutions designed using custom code are more accurate, streamline the compliance processes, and are able to continually monitor an organization’s adherence to the very complex array of incoming regulations. By automating mundane tasks that previously consumed the healthcare compliance team’s time and allowing them to simplify the compliance workflows and integrate into the existing systems, the custom coding solutions not only reduce the risk of a compliance-related fine but also help save on resources and reduce overheads that come with the compliance machinery.