HHS and the CMS are working with health plans to boost patient confidence in the wake of new health care technologies coming online, experts said at AHIP’s recent Consumer Experience & Digital Health Forum.
Cybersecurity concerns can be a significant barrier as breaches, hacking and ransomware increase, said Melanie Fontes Rainer, director of the Office for Civil Rights at HHS. There has been a 60% increase in the number of people affected by health data breaches in 2023, and 77% of large breaches last year were the result of cyberattacks. Meanwhile, over the past four years, there has been a 239% increase in large breaches involving hacking reported to the OCR.
AI and other technologies will be most effective when patients are confident their privacy is protected, Fontes Rainer said. To that end, HHS is updating its HIPAA security rule and aims to finish before the end of the year. It has also released YouTube videos and newsletters to educate health care organizations on ransomware.
Patients and members must also be confident that technologies will not worsen their health care experience, such as through discriminatory algorithms used in decision making. “We’ve seen value assessment tools where the life of a person with a disability is valued less,” Fontes Rainer said.
Fontes Rainer noted that Section 1557 of the Affordable Care Act, which prohibits discrimination in covered health programs or activities, has not changed just because technology has evolved. Health care organizations “were always on the hook for nondiscrimination in health care activities. The AI-related provision is tech-neutral and applies to patient care decision support tools, which includes AI tools, clinical algorithms, flowcharts, eligibility tools, risk prediction tools and more,” Fontes Rainer said.
HHS recognizes the need for guardrails that permit but guide the use of AI and underscores that it should assist, not replace, humans. It is also working to ensure civil rights are upheld in machine learning technologies such as Google Translate.
“These things can be helpful in a pinch but are not a substitute for actual medical translation,” Fontes Rainer said.“There has to be human validation.”
Modernizing the US digital health infrastructure
In a separate session at the AHIP conference, panelists discussed HHS’ multi-agency AI task force. The task force is “developing strategies on where we think public interest is and the appropriate role government and HHS should play through all our agencies,” said Micky Tripathi, assistant secretary for technology policy with the National Coordinator for Health Information Technology. Tripathi said the agency considers:
- Where to avoid disrupting innovation if things are going well
- Where guardrails may be needed
- How to motivate innovation.
The agency is conducting external stakeholder outreach meetings and plans to release a strategic plan in January 2025.2 It also plans to continue writing rules related to AI, said Alexandra Mugge, chief health informatics officer with the CMS. The agency is also working on a rule for interoperability and prior authorization geared toward pharmaceuticals, and it is “always looking across all programs to see where there are opportunities to standardize or increase data exchange or interoperability.”
Interoperability roadmap
These regulatory actions all feed into an interoperability roadmap under development by the CMS. The project began a year ago with a framework, Mugge said, but stakeholders felt it wasn’t actionable enough and moved to create a plan with more action items.
The CMS is working with regulated and commercial payers to bring everyone into the fold, and it aims to align with the ONC’s work on standards and the federal strategic plan. Interoperability will take time, Mugge said, but “federal agency coordination in the health IT space is better than it’s ever been.”
__________________________
Take advantage of SmartBrief’s FREE email newsletters for health care CIOs and IT professionals, which are among the company’s more than 280 industry-focused newsletters.
link