HHS Deputy Secretary Discusses Priorities

HHS Deputy Secretary Eric D. Hargan Keynoter at the “AcademyHealth 2019 Health Datapalooza” https://www.academyhealth.org event held in Washington D.C. March 27-28, told the attendees how his office has undertaken an initiative called the “Deputy Secretary’s Innovation and Investment Summit.

The goal is to examine the innovation and investment landscape within the healthcare sector, seek emerging opportunities, and help the government facilitate more investment and accelerated innovation.”

He reports, “About 100,000 American adolescents and young adults experience a first episode of psychosis each year, but we know that an early comprehensive intervention in individuals experiencing their first psychotic episode can significantly increase their quality of life.”

To deal with mental health issues, the Deputy Secretary reports his office is working with the private sector on “Patient Empowering Technologies” (PETS) a program to try to better understand how technologies can be used to empower patients. HHS is examining how to use PETS effectively to deal with serious mental illness.

He continued to say that one intervention that works when treating mental illness is referred to as “Coordinated Specialty Care” (CSC) where an evidence-based multi-component team has been able to improve outcomes, shorten inpatient stays, and reduce costs among young people with psychotic symptoms.

Currently, almost every state has at least one CSC program with a total of more than 260 CSC programs nationwide. However, some people in need of CSC may live some distance from the CSC program, so this may be a good opportunity for technology to be used to help individuals in rural communities take part in the program.

In addition, NIH https://www.nih.gov and the Substance Abuse and Mental Health Services Administration (SAMSHA) https://samhsa.gov are beginning to explore how technology assistance can help patients with mental health disorders and be integrated into existing care pathways

The Deputy Secretary mentioned how HHS is also exploring how technology can best help providers. Physicians report that when they are prescribing a drug, they often are picking a drug without knowing how much it will cost their patient or whether it is even covered by insurance.

He suggests that by using a real-time pharmacy benefit tool, it would be possible for the provider and patient to instantly find out which drugs are covered by insurance, how much they cost, and how much they will cost the patient, plus more. By using technology, the doctor would be able to find specific information on authorizations needed for a particular drug.

He also pointed out that another area getting attention is the development and use of medical devices which are posing challenges for FDA’s work. Presently, FDA is looking at how to modernize the traditional 510(k) pathway for medical devices since the approval pathway is 43 years old and is considered geriatric.

He said, “One step forward would be to establish an alternative 510(k) pathway to allow manufacturers of certain well-understood device types to rely on objective safety and performance criteria, rather than using the typical approval pathway which compares the product technologically to an already marketed device.”

We’ve also taken steps toward more incorporation of real-world evidence into safety reviews of medical devices. This entails collecting the data as part of routine clinical care and also obtain data from devices themselves.

To unlock the next generation of medical advances, it is important to look at how to monitor the safety and effectiveness of software by not relying on static algorithms but to use artificial intelligence to constantly adapt and learn.

Summing up, “Lastly, we are paying attention to the potential for new technologies to treat or prevent one of the most costly health conditions, kidney disease. Now we need to reorient our treatment of kidney disease with more convenient options, like at home or peritoneal dialysis.”.

HHS’s Office of the Chief Technology Officer has launched Kidney X  https://www.hhs.gov/cto/index.html, a public private partnership with the American Society of Nephrology to spur development through prize competitions of transformational products like wearable or implantable artificial kidneys.

The first competition “Redesign Dialysis” is encouraging and supports innovators to develop new technologies and approaches that could usher in the next generation of dialysis products. So far, 165 submissions have been received including a number of proposals that could possibly advance the artificial kidney.

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