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Five regulatory facets we’re focused on

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When I first started working in health IT, we had to explain what an EHR was to anyone we spoke with. Almost all hospitals and physician practices still used paper charts. The exchange of patient information was minimal except for that done by individuals carrying stacks of paper with them from visit to visit. And, as hard as it is to imagine, ONC did not yet exist.

The industry has since moved through the HITECH years, when EHRs were adopted more rapidly than companies could deploy them, with the vast majority of clinicians now saying they could never live without health IT to assist them in care delivery. ONC has certainly been empowered with and embraced its role as the primary regulator of health information technology, and numerous additional federal agencies and every state government out there now regulate health IT. It’s one of the fastest ramp-ups of a regulatory environment on an industry in the last century, and both software developers and the healthcare clients we serve are feeling the challenge of navigating that rocky terrain.

Following are a few recent and upcoming regulatory matters, as well as general policy trends, we’re tracking here at Altera:

1. The value of clinical data

A healthcare organization sits at the center of the image with various means of data exchange surrounding it, including a computer, mobile phone and paper documents.Today, we still see ripple effects of the push for widespread EHR adoption that started when President Obama first took office. Digitization of medical records has generated a lot of excitement around the potential uses for the rich health data that lies within. Providers want to harness the data to improve patient outcomes and personalize care further; payers want to better manage high-cost, high-risk members/beneficiaries; and public health entities want to advance research, as we recently saw in action during the height of the COVID-19 pandemic.

Accordingly, our clients are tasked with documenting and reporting clinical data for all kinds of purposes. However, the requirements for reporting at the federal level are known to conflict with some at the state and other levels, and we still see duplication of reporting efforts thanks to a lack of harmonization of the laws and regulations. This makes it challenging for provider organizations to comply with all relevant programs in an efficient manner—and the fines for noncompliance can be steep.

2. Privacy and security trends

As digital technology use continues to grow in healthcare, so do the privacy and security implications. While approximately a dozen states have already rolled out comprehensive privacy legislation, policymakers at the federal level are increasingly looking at laws that would potentially be similar to the European Union’s General Data Protection Regulation (GDPR), as well as the California Consumer Privacy Act (CCPA). However, no action has yet been taken to put a national privacy framework in place.

Who has the right to access what patient data also continues to come under question. Since the Supreme Court overturned Roe v. Wade in 2022, some states have been looking at or passing laws to protect medical records from prosecutorial scrutiny or allow patients to request that certain sensitive health data be held back from exchanged information or their patient portal. As a result, the intersection of data segmentation and privacy has become an area of significant focus in the health IT industry. (For example, patients experiencing domestic violence may not want their reproductive data accessible to their partner.)

Third, Congress is eyeing privacy and security within the context of AI, not just in healthcare but across the board, on a bipartisan basis. Many technology companies are eagerly awaiting guidance or legislation around AI so they know what the guardrails are as they progress with related work.

3. Information blocking progress

Since the passage of the 21st Century Cures Act in 2016, stakeholders across the industry have been expanding their focus on varied information sharing use cases and working to avoid any inadvertent repercussions for information blocking. Sept. 1 represented a turning point in this regulatory journey: health IT, health information exchanges and health information networks may now be fined up to $1 million per violation of the associated regulation. However, HHS has yet to release the provider disincentive rule, so compliance may not be a major priority for some provider organizations at this time.

Altera recognizes the importance of successful information sharing as a critical tool to optimize patient care, and we have been adjusting our infrastructure, processes and health IT solutions to enhance this capability. Additionally, we deploy annual, mandatory training to all employees and new hires on information-blocking requirements and the way that each role in the company plays a key part in supporting our clients and partners amid this industry shift.

4. Value-based care stagnation

64% of patients support value-based care over fee-for-service models.Over the last decade or so, while Congress and various administrations have continued to discuss value-based care as a tool in the fight to contain healthcare costs and improve patient outcomes, progress has stalled when it comes to significant new programs and the number of providers participating. Value-based care incites the delivery of certain types or patterns of care (e.g., screening for high blood pressure, administering flu shots), but even years into the efforts to move away from fee-for-service payment models, the efforts by both the government and commercial payers still do not fully account for (or reward) comprehensive care coordination that measurably move us toward the true vision for value-based care.

One national survey found that 64% of patients support value-based care over fee-for-service models, though terms like “patient-first care” and “quality-focused care” resonate more with them. While greater patient education is needed to reduce confusion regarding alternative payment models and why they can benefit patients, it is clear there is an appetite for this shift from patients and providers alike if the policymakers can get over hurdles currently stalling the effort.

5. Looking ahead

With an election year approaching, expect a swell of legislative and regulatory activity related to healthcare and health data in late 2023 and early 2024 as incumbents attempt to court voters. Healthcare tends to be a hot-button issue on the campaign trail, so we are likely to see issues with bipartisan support at the fore, such as surprise billing and finetuning patient privacy. Of course, the long-term fate of any bill passed will depend on what the next Congress looks like.

No matter what regulatory changes lie ahead, Altera stands ready and committed to supporting our clients through whatever new challenges they face.

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