Now, as these integrated and digitalized care delivery models keep gaining more prominence, a lot of new regulatory protocols are also coming into the picture. The reasoning behind this is fairly simple; many of the innovative technologies were not primarily designed for the healthcare industry, so provisions need to be taken to ensure the safety and wellbeing of patients. As a result of this, healthcare organizations are now facing an added burden of complying with all the new technical regulations, let alone the existing protocols that were already complex. Besides, managing and complying with all these new regulations via prevailing manual processes can no longer be an option. It will not only be a time and cost-intensive process, but it will also significantly affect the first-mover advantage of the life sciences and healthcare organizations. Thus, the life sciences and healthcare organizations must revamp and take a more strategic, data-driven and holistic route to meet such convoluted regulatory guidelines.
Interestingly, this understanding inspired Hema Lakkaraju to launch HAYAG, a data-driven strategic compliance consulting and software company. The company’s motto is to revolutionize the healthcare domain with its inventive compliance strategies. To that end, HAYAG has developed AI-based tools that can provide and manage all the strategic compliance requirements of an organization through a single platform. These data-driven tools enable healthcare organizations to define the customized compliance controls for a project or a product within minutes, thereby devising a complete step-by-step compliance roadmap in the shortest time.
The One-Stop-Shop for “Compliance by Design” Strategies
Notably, Hema has more than a decade of experience working on information technology (IT), cybersecurity and governance, and data management aspects of compliance. And it is indeed Hema’s expertise that has enabled HAYAG to carve a niche as a one-stop-shop that caters to all compliance requirements through a unique “compliance by design” strategy approach. “We implement all the regulatory controls and roadmap during the onset of a project itself. As a result, our clients can slash off millions of dollars from their projected expenditure and save up to 30-40 percent of their operational costs,” says Hema, founder and CEO at HAYAG.
Going the extra mile, HAYAG takes a tailored approach to fine-tune the compliance software as well. For each product or project, the company takes into account the client’s vision and mission, data, regulatory markets, and the purpose of the product. This helps clients in cutting down another 30 percent of their operational costs and time. “Our aim is to bring a clear sense of transparency and collectiveness between the different teams of an organization while catering to all of their compliance requirements,” avers Hema.
AI Tools Designed for Unique Organizational Needs
HAYAG has developed AI-based tools that can provide and manage all the strategic compliance requirements of an organization through a single platform
HAYAG has designed different software and service packages that correlate to every kind of organization within the life sciences and healthcare ecosystem. For instance, HAYAG PROD+ is a complete product-focused tool that can track, manage, and document every compliance-related activity of a smaller firm, offering them real-time insights through point-and-click reporting and intuitive dashboards. Whereas HAYAG PROJ+ is a project-focused tool designed for comprehensive and robust regulatory compliance of mid and large-size organizations that have multiple projects. In addition to that, HAYAG has developed a one-of-a-kind enterprise solution for larger firms, HAYAG application lifecycle management (ALM), with built-in integrated regulatory assessment for products and projects. Therefore, clients do not have to create additional regulatory procedures for their applications, as the requisites for complying with privacy and other regulatory standards like Food and Drug Administration (FDA),General Data Protection Regulation(GDPR), Health Insurance Portability and Accountability Act (HIPAA), Consumer Privacy Protection Act (CPPA),National Institute of Standards and Technology (NIST), and International Organization for Standardization (ISO) are already aligned in one place.
At this point, the extent to which these compliance packages help in accelerating product launches can be best explained through one of the recent collaborations of HAYAG with a large enterprise. The client was quoted huge monetary expenses and a lengthy timeline by their previous compliance service provider. But as the client was concurrently developing the product, the quoted details were deemed inapt by them. It is when the client consulted with HAYAG. The team at HAYAG provided a detailed assessment report and a complete strategical roadmap denoting priority-wise objectives, controls within two days. “They were quite surprised and impressed about how we could come up with such a detailed plan at a fraction of the price in a couple of days,” remarks Hema.
Basking in the glory of such competencies, HAYAG is now all set to expand to the markets in Asia and Europe. Meanwhile, HAYAG is also developing solutions that can spur the integration of fintech solutions with the healthcare industry. At the same time—as Hema emphasizes—HAYAG is committed to aid the mushrooming healthcare startups in their regulatory efforts. “We took a pledge – Pledge 50 – at the end of last year that we are going to have at least 50 health startups use our software solutions to meet their regulatory efforts,” affirms Hema. The company has aided 10 health startups since then. “We were able to provide the complete assessment, including the documents and regulatory controls, within a day. They were quite happy that they now want to come back and work with us again for other products,” highlights Hema. “And this is the kind of future we are currently looking at.”