Author: Newsbit

The United States has rejected amendments adopted in 2024 by members of the World Health Organization to its legally binding health rules aimed at improving preparedness for future pandemics following the disjointed global response to Covid-19.

The Department of State and Department of Health and Human Services said in a statement they had transmitted on Friday the official US rejection of the amendments to the International Health Regulations, which were adopted by consensus last year.

The amendments introduced a new category of “pandemic emergency” for the most significant and globally threatening health crises in an effort to shore up the world’s defenses against new pathogens.

“Developed without adequate public input, these amendments expand the role of the WHO in public health emergencies, create additional authorities for the WHO for shaping pandemic declarations, and promote WHO’s ability to facilitate ‘equitable access’ of health commodities,” the US statement said.

“Terminology throughout the 2024 amendments is vague and broad, risking WHO-coordinated international responses that focus on political issues like solidarity, rather than rapid and effective actions,” said the statement, jointly issued by Secretary of State Marco Rubio and Secretary of Health and Human Services Robert F. Kennedy Jr.

Kennedy, who has a long history of sowing doubt about vaccine safety, had slammed the WHO in a video address to the Assembly during its vote on a separate pandemic agreement, saying it had failed to learn from the lessons of the pandemic.

That pact, which was adopted in Geneva in May after three years of negotiations, aims to ensure that drugs, therapeutics and vaccines are globally accessible when the next pandemic hits. It requires participating manufacturers to allocate a target of 20% of their vaccines, medicines and tests to the WHO during a pandemic to ensure poorer countries have access.

US negotiators left discussions about the accord after President Donald Trump began a 12-month process of withdrawing the US – by far the WHO’s largest financial backer – from the agency when he took office in January. Its exit means the US would not be bound by the pact.

Kennedy and Rubio said on Friday that their rejection protects US sovereignty. The IHR amendments and the parallel pandemic pact leave health policy to national governments and contain nothing that overrides national sovereignty, however. Reuters

The HIMSS Electronic Health Record Association has responded to a new request for information from the U.S. Department of Health and Human Services, seeing it as a critical opportunity to examine regulations that don’t reflect current technology or market realities, and to correct “misaligned” approaches to rulemaking.

The EHRA submitted comments about its reform and deregulatory priorities to the HHS in response to its RFI, “Ensuring Lawful Regulation and Unleashing Innovation To Make America Healthy Again Request for Information.”

Why it matters
The coalition of health technology vendors has long held that an expansion of Food & Drug Administration oversight of medical device regulation to technology already subject to oversight through the Office of the National Coordinator for Health Information Technology Certification Program is beyond the statutory boundaries of the 21st Century Cures Act.

“As the federal government seeks to modernize its regulatory approach and support innovation across healthcare, we urge HHS to focus on clarity, alignment with statutory intent and the elimination of low-value or duplicative regulatory requirements,” the EHR Association said in its July 14 comment letter.

The organization’s position is that EHR systems should not be regulated as medical devices, and certain guidance issued in 2022 is having “a chilling effect on developers’ willingness to invest” in tools needed to support public health and value-based care programs.

“The EHR Association urges HHS to rescind the FDA’s Final Guidance on Clinical Decision Support Software, which clearly conflicts with the seven principles outlined in Executive Order 14219,” the organization said.

“Most notably, the guidance lacks statutory grounding, introduces legal ambiguity, imposes excessive costs and deters innovation.”

Instead, the EHR Association said the FDA should “reinstate or revise the 2019 draft guidance” to “explicitly exclude CDS functionality embedded in certified EHRs” and eliminate new regulatory constructs, including time-critical decision-making and automation bias, introduced in the latest guidance.

The trade organization also said other HHS regulations and policies also fall within the deregulatory scope outlined in the Trump administration’s Executive Order 14212.

These include clarifying Predetermined Change Control Plans requirements, addressing bias in classifying products as devices that impose user fees, modifying outdated HIT certification testing tools and better defining certain interoperability requirements.

The organization also urged HHS to clarify electronic case reporting requirements – automated reporting of public health conditions, including chronic disease indicators – and “provide adequate funding and technical support” for the Centers for Disease Control and state, tribal, local and territorial authorities.

“Instead of deregulation in this case, success relies on stability, coordination and capacity building,” the EHR Association said.

The larger trend
The FDA said in January that while it is committed to deploying new medical devices faster, it will take a science-based approach to its requirements for medical devices powered by artificial intelligence and machine learning.

Then, in April, the Assistant Secretary for Technology Policy updated guidance that healthcare organizations use to assess and optimize the safety of their EHRs. The 2025 Safety Assurance Factors for EHR Resilience Guides contain CURES Act revisions, including the use of AI for clinical care, cybersecurity and integration of FDA-approved medical device data into EHRs.

On the record
“As the federal government seeks to modernize its regulatory approach and support innovation across healthcare, we urge HHS to focus on clarity, alignment with statutory intent, and the elimination of low-value or duplicative regulatory requirements,” the EHRA said in its letter. “The recommendations in this response reflect the practical realities our member companies face in delivering high-quality, interoperable and patient-centered digital health tools.” Healthcare IT News

By 2030, GCCs in healthcare, life sciences sectors will increase to 160 centres from 100 now

India’s Global Capability Centers (GCCs) have steadily evolved from cost-saving outposts to critical infrastructure in the global healthcare value chain. Nowhere is this transformation more evident than in the life sciences and healthcare (LSHC) sector – where digital health, regulatory services, and AI-enabled analytics are increasingly being delivered not just from India’s metros, but from cities once considered peripheral to the innovation map.

Tier-2 cities are not merely absorbing overflow. They are actively stepping into the spotlight. Today, India hosts over 100 LSHC GCCs, employing more than 280,000 professionals. By 2030, that number is expected to reach 160 centers and over 420,000 employees. The shift underway is not just quantitative. It is geographic. And strategic as well.

“Tier-2 cities are emerging as ideal candidates for housing next-generation LSHC GCCs,” Ritu Baliya, Associate Director – Strategy, Healthark Insights, told The Hans India. “Strong policy support, sector-specific academic pipelines, and improving infrastructure are enabling global enterprises to expand with confidence – not just at lower cost, but with greater long-term alignment”. Ritu Baliya, with over 10 years of experience, has been advising life sciences and healthcare clients worldwide on strategy and market insights. She also supports the growth of Global Capability Centers by helping organizations tap into India’s evolving innovation and talent ecosystem.

From Kochi to Warangal, Vadodara to Coimbatore, a new network of cities is rewriting the operational map for life sciences capability. These urban centers are now offering what once only metros could: talent continuity, access to clinical and regulatory institutions, and robust digital infrastructure. Importantly, they are doing so with lower attrition, higher workforce stability, and sharper sectoral focus. State governments have accelerated this trend by moving from generic IT policies to GCC-specific blueprints. Telangana, already a recognized tech leader, is seeing growing GCC activity in Warangal, Karimnagar, and Nizamabad, building on Hyderabad’s momentum. As per ANSR’s Q4’23 GCC report, 3 of 14 new GCCs and 7 of 29 expansions in India occurred in Telangana alone. This momentum is not accidental. With commercial property rates and power tariffs lower than in states like Maharashtra and Karnataka, and a data center pipeline expected to grow from 44 MW in 2023 to 128 MW by 2026, the state is creating the right conditions for digital health operations to flourish. It also helps that Telangana has the highest percentage of employable youth (18–21 years) in India, according to the Wheebox National Employability Test.

Andhra Pradesh, too, is moving with intent. The state is positioning Visakhapatnam as a strategic Tier-2 hub for LSHC GCCs by offering rental subsidies of`2,000 per seat for 24 months, power incentives for five years, and housing and education allowances of up to`1 lakh per employee. Combined with an affordable, trained talent pool and a growing appetite for public-private collaboration, AP’s model is quietly gaining traction.

In Gujarat, the state’s life sciences backbone is being augmented with policy muscle. Gujarat’s vision includes attracting 250 new GCCs, creating over 50,000 jobs, and securing Rs 10,000 crore in investments. GCCs operating in the state benefit from 100 per cent electricity duty waivers for five years, 80 per cent reimbursement of quality certification fees, and provident fund reimbursements – 100 per cent for female employees and 75 per cent for male employees. For companies operating in regulatory affairs, R&D, and clinical operations, Gujarat offers both capability and continuity.

Tamil Nadu is driving a MedTech and digital health GCC agenda with Rs 2,295 crore allocated toward expanding operations beyond Chennai. Coimbatore, Madurai, and Trichy are seeing early momentum as the state leverages its industrial legacy, IT base, and deep manufacturing ecosystem to attract global healthcare enterprises. Ongoing investments in IT parks and industrial corridors are reinforcing this long-term intent.

Even states that were previously outside the GCC narrative are making credible plays. Uttar Pradesh, for instance, has introduced a targeted GCC policy aimed at channeling investment into Lucknow and Kanpur – home to premier institutions like CDRI and SGPGI. Companies setting up in eligible zones receive land subsidies of up to 50 per cent, 100 per cent stamp duty exemptions, and capital investment subsidies. With foundational infrastructure in place and a large workforce base, UP is building a research-oriented positioning that complements its demographic scale.

The corporate response has been pragmatic – and increasingly bold. In Kochi, Aster DM Healthcare’s Rs 850 crore investment reflects confidence in Kerala’s strategic push toward high-impact healthcare. The Invest Kerala Global Summit has spotlighted Kochi’s readiness for innovation-driven GCCs. In Coimbatore, firms are experimenting with digital twin models – simulating drug processes, piloting MedTech innovations, and fine-tuning delivery strategies before global rollouts. Vadodara, long a stalwart of the pharmaceutical industry, is attracting attention from global players looking to scale regulatory and analytics capabilities outside saturated metros. And Warangal – powered by its proximity to Hyderabad, NIT-trained talent, and operational setups by LTI Mindtree and Genpact – is becoming a blueprint for how smaller cities can host enterprise-critical operations.

“The attractiveness of Tier-2 cities lies not just in cost arbitrage,” Baliya notes. “It’s in the growing belief that operational excellence and innovation maturity can be achieved outside traditional hubs – with the right partners, policies, and infrastructure.” This shift is more than a footnote in India’s GCC evolution. It signals the emergence of a broader, more resilient ecosystem – one that supports diversification, accelerates hiring, and anchors capability where it’s most scalable. For global life sciences companies, Tier-2 cities offer a rare trifecta: affordability, depth, and dependability.

Importantly, this decentralization aligns closely with India’s macroeconomic ambitions. As Telangana and other forward-looking states aspire toward the $1 trillion economy mark, the integration of Tier-2 cities into the global services grid isn’t just an operational play – it’s a national strategy. It widens the talent funnel, localizes innovation, and deepens India’s relevance in global healthcare supply chains.

As the healthcare industry becomes more data-intensive, digitally managed, and globally distributed, Tier-2 cities are no longer the second option. They are rising – with intent, with talent, and with a model that fits the future of healthcare delivery. The Hans India