Industry stakeholders, FDA and CMS officials, and health technology companies agreed successfully integrating home health technologies in the health care ecosystem requires consistent regulation laying out proper data privacy practices, telehealth accessibility and artificial intelligence guidelines. But lawmakers are already struggling to pass a two-year telehealth extension and engrossed in partisan clashes over potential data privacy and artificial intelligence legislation, all of which could slow deployment of home health technologies.
FDA Commissioner Robert Califf said at a listening session Thursday (July 24) on the agency’s “Home as a Health Care Hub” that virtual devices will increasingly leverage digital capabilities to integrate health systems.
“It’s important to understand these challenges cannot be solved by the FDA alone,” Califf said. “One of the goals of this initiative is to make sure the conversation considers the perspectives of the many people who will be impacted and who can have an impact.”
Artificial Intelligence
Many home health technologies use artificial intelligence to treat patients, including chat-bot caregiver capabilities and digital therapeutics. Targeting bias in AI is essential to ensure that home health technologies can serve all populations, according to stakeholders.
Ian McKay, cloud principal solution architect at Amazon Web Services, said he works with digital health companies to develop their home health solutions.
“This has resulted in a ladder of capabilities that support the entire connected care ecosystem, from devices in the home through big data analytics and the AI machine learning in the cloud,” McKay said.” We see and are helping solve many challenges along the entire technology chain, from in home configuration, internet connectivity, especially in rural areas or for mobile clinics, to communications and IT standards.”
Lawmakers and digital health stakeholders are grappling with how to best regulate emerging AI technologies. While lawmakers weigh legislation, some stakeholder groups would like to see increased action through existing regulatory agencies. A handful of lawmakers are considering the creation of a new regulatory agency that would solely focus on regulating AI.
FDA has put out a draft guidance on change control plan for emerging AI health technologies that calls for companies to submit future measures for mitigating bias and other algorithmic errors after the technology enters the market when they submit initial applications for approval.
Data privacy
Home health technologies often collect patient data and sometimes transmit that data to practitioners for monitoring chronic diseases. In the absence of a national data privacy framework, health tech companies find it challenging to comply with the patchwork of state privacy laws.
Paul Conway, chair of policy global affairs for the American Association of Kidney Patients, said he is concerned that health home devices don’t have sufficient privacy standards to protect patients.
“We are particularly concerned about anything that would be on the IT safety side, in terms of hackability of devices,” Conway said. “Home based use of devices would create a privacy issue for patients, meaning more data is collected than the patient is aware of. That would have to be something that’s disclosed.”
Consumer Technology Association President Gary Shapiro said during the meeting that although the Health Insurance Portability and Accountability Act protects some health data, more work needs to be done to protect sensitive health information as health home technologies become increasingly integrated in patient care.
“Many stakeholders in care fall outside of HIPAA jurisdiction,” Shapiro said. “That’s why CTA has long held a position that we need comprehensive privacy legislation that preempts varying state laws to build one standard that will engender trust. But I think we are ready to address these issues as a country, and I’m very hopeful about it.”
The latest federal privacy bill American Right to Privacy Act was stalled by partisan tensions over the bill’s private right of action. Republicans are against opening up technology giants to increased litigation over privacy issues, which may hinder technological development. Democrats are supportive of individuals’ right to hold technology companies accountable.
APRA had a carve out for health data that would not preempt state privacy legislation. Health technology stakeholders lamented that the bill would not help companies that serve patients in multiple states streamline their privacy protocols.
Telehealth
Home health technologies that monitor patients with chronic conditions often incorporate telehealth when a patient needs to connect with their physician. But stakeholders said uncertainty over whether telehealth will be accessible to Medicare beneficiaries may hinder the incorporation of home health technology.
Martin Mendoza, CMS chief health equity officer and director of the CMS Office of Minority Health, urged stakeholders to comment on the 2025 physician fee schedule, including provisions that would maintain telehealth flexibilities.
“I’ll briefly share just a few specific policy updates that you might consider as you drive your work on home health,” Mendoza said. “First is the recently finalized section 1557 which is a set of regulations and guidelines for all federally funded health entities and programs, including federal, state and local health programs, including those administered by CMS. It applies to all health care organizations, including providers, practices, facilities and home health care agencies, insurers, health plans and healthcare insurance marketplaces. It covers both telehealth and in person.”
CMS outlined in the proposed physician fee schedule its plans to repeal crucial telehealth flexibilities that would subject most digital care to pre-pandemic regulations unless Congress extends the flexibilities before they expire.
Stakeholders couch the telehealth terminology in the fee schedule as CMS urging Congress to act legislatively on expanding flexibilities, saying it’s a sign of the agency’s willingness to implement policies. But telehealth stakeholders are concerned about Congress running out the clock so close to when waivers expire at the end of the year. CMS is expected to issue the final fee schedule rule the beginning of November and it will go into effect Jan. 1.
Privacy, Telehealth, AI Regs Needed To Expand Home Health
bgov.com
July 31, 2024 3:12 pm
Industry stakeholders, FDA and CMS officials, and health technology companies agreed successfully integrating home health technologies in the health care ecosystem requires consistent regulation laying out proper data privacy practices, telehealth accessibility and artificial intelligence guidelines. But lawmakers are already struggling to pass a two-year telehealth extension and engrossed in partisan clashes over potential data privacy and artificial intelligence legislation, all of which could slow deployment of home health technologies.
FDA Commissioner Robert Califf said at a listening session Thursday (July 24) on the agency’s “Home as a Health Care Hub” that virtual devices will increasingly leverage digital capabilities to integrate health systems.
“It’s important to understand these challenges cannot be solved by the FDA alone,” Califf said. “One of the goals of this initiative is to make sure the conversation considers the perspectives of the many people who will be impacted and who can have an impact.”
Artificial Intelligence
Many home health technologies use artificial intelligence to treat patients, including chat-bot caregiver capabilities and digital therapeutics. Targeting bias in AI is essential to ensure that home health technologies can serve all populations, according to stakeholders.
Ian McKay, cloud principal solution architect at Amazon Web Services, said he works with digital health companies to develop their home health solutions.
“This has resulted in a ladder of capabilities that support the entire connected care ecosystem, from devices in the home through big data analytics and the AI machine learning in the cloud,” McKay said.” We see and are helping solve many challenges along the entire technology chain, from in home configuration, internet connectivity, especially in rural areas or for mobile clinics, to communications and IT standards.”
Lawmakers and digital health stakeholders are grappling with how to best regulate emerging AI technologies. While lawmakers weigh legislation, some stakeholder groups would like to see increased action through existing regulatory agencies. A handful of lawmakers are considering the creation of a new regulatory agency that would solely focus on regulating AI.
FDA has put out a draft guidance on change control plan for emerging AI health technologies that calls for companies to submit future measures for mitigating bias and other algorithmic errors after the technology enters the market when they submit initial applications for approval.
Data privacy
Home health technologies often collect patient data and sometimes transmit that data to practitioners for monitoring chronic diseases. In the absence of a national data privacy framework, health tech companies find it challenging to comply with the patchwork of state privacy laws.
Paul Conway, chair of policy global affairs for the American Association of Kidney Patients, said he is concerned that health home devices don’t have sufficient privacy standards to protect patients.
“We are particularly concerned about anything that would be on the IT safety side, in terms of hackability of devices,” Conway said. “Home based use of devices would create a privacy issue for patients, meaning more data is collected than the patient is aware of. That would have to be something that’s disclosed.”
Consumer Technology Association President Gary Shapiro said during the meeting that although the Health Insurance Portability and Accountability Act protects some health data, more work needs to be done to protect sensitive health information as health home technologies become increasingly integrated in patient care.
“Many stakeholders in care fall outside of HIPAA jurisdiction,” Shapiro said. “That’s why CTA has long held a position that we need comprehensive privacy legislation that preempts varying state laws to build one standard that will engender trust. But I think we are ready to address these issues as a country, and I’m very hopeful about it.”
The latest federal privacy bill American Right to Privacy Act was stalled by partisan tensions over the bill’s private right of action. Republicans are against opening up technology giants to increased litigation over privacy issues, which may hinder technological development. Democrats are supportive of individuals’ right to hold technology companies accountable.
APRA had a carve out for health data that would not preempt state privacy legislation. Health technology stakeholders lamented that the bill would not help companies that serve patients in multiple states streamline their privacy protocols.
Telehealth
Home health technologies that monitor patients with chronic conditions often incorporate telehealth when a patient needs to connect with their physician. But stakeholders said uncertainty over whether telehealth will be accessible to Medicare beneficiaries may hinder the incorporation of home health technology.
Martin Mendoza, CMS chief health equity officer and director of the CMS Office of Minority Health, urged stakeholders to comment on the 2025 physician fee schedule, including provisions that would maintain telehealth flexibilities.
“I’ll briefly share just a few specific policy updates that you might consider as you drive your work on home health,” Mendoza said. “First is the recently finalized section 1557 which is a set of regulations and guidelines for all federally funded health entities and programs, including federal, state and local health programs, including those administered by CMS. It applies to all health care organizations, including providers, practices, facilities and home health care agencies, insurers, health plans and healthcare insurance marketplaces. It covers both telehealth and in person.”
CMS outlined in the proposed physician fee schedule its plans to repeal crucial telehealth flexibilities that would subject most digital care to pre-pandemic regulations unless Congress extends the flexibilities before they expire.
Stakeholders couch the telehealth terminology in the fee schedule as CMS urging Congress to act legislatively on expanding flexibilities, saying it’s a sign of the agency’s willingness to implement policies. But telehealth stakeholders are concerned about Congress running out the clock so close to when waivers expire at the end of the year. CMS is expected to issue the final fee schedule rule the beginning of November and it will go into effect Jan. 1.