President Trump declared the opioid addiction epidemic a public health emergency on October 25, 2017. The White House made it clear that this declaration would allow officials to remove barriers to the prescribing of...more
The Senate’s unanimous passage of the Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017 (S.870) on September 26th is an encouraging step forward for modernizing telehealth...more
On July 31, 2017, President Donald Trump’s Commission on Combating Drug Addiction and the Opioid Crisis recommended that he declare the opioid epidemic a national emergency. In August 2017 and again on October 16, 2017, the...more
On September 15, 2017, the Texas Medical Board (Board) released proposed rules regarding telemedicine and mental health services (Proposed Rules) to implement Senate Bill 1107, which was passed on May 11, 2017. Most notably,...more
The Enhanced Nurse Licensure Compact (Compact) has now been adopted by 26 states, which means the Compact will be taking effect on January 19, 2018. Nurses who seek to practice telemedicine and deliver in-person care across...more
The Office of the National Coordinator for Health Information Technology recently released a report (the Report) detailing user experience research on patient access to health data. The Report sought to examine the...more
On May 3, 2017, the Creating Opportunities Now for Necessary and Effective Care Technologies for Health Act of 2017 (S. 1016) (CONNECT Act of 2017) was reintroduced by the same six senators who had initially introduced the...more
The Electronic Health Records (EHR) Incentive Program run by Centers for Medicare and Medicaid Services (CMS) garnered attention again last week following the release of a report by the Office of Inspector General of the US...more
As one of the last states to retain highly restrictive (and arguably anti-competitive) telemedicine practice standards, health care providers, regulatory boards, technology companies, payors and other stakeholders have been...more
On April 24, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced a Health Insurance Portability and Accountability Act of 1996 (HIPAA) settlement in the amount of $2.5 million based on...more
Late last month, Senator Cory Gardner (R-CO) and Senator Gary Peters (D-MI) introduced Senate Bill 787, the Telehealth Innovation and Improvement Act (Telehealth Improvement Act), which is focused on expanding Medicare’s...more
Utah is one of the many states that started off 2017 with proposals to change its existing telehealth laws and regulations. Proposed Utah HB 154 (the Proposed Bill), endorsed by Ken Ivory and Allen Christensen, amends the...more
Texas telehealth requirements will significantly change in the near future if Texas Senate Bill 1107 is passed into law, which removes the controversial “face-to-face” or in-person consultation requirement to establish a...more
Arkansas currently has one of the most restrictive telemedicine environments in the country, and was one of the last states to require an in-person examination to form a provider-patient relationship. Prior to September 2016,...more
The Final Rule published by the US Department of Health and Human Services on January 18, 2017, largely avoids major modifications to the Common Rule. However, it specifically addresses creation of biospecimen and data...more
2/7/2017
/ Clinical Trials ,
Department of Health and Human Services (HHS) ,
Human Rights ,
Informed Consent ,
IRB ,
Medical Devices ,
Medical Research ,
NPRM ,
Proposed Regulation ,
Scientific Research ,
The Common Rule
On December 7, 2016, the US Congress enacted the 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment,...more
1/21/2017
/ 21st Century Cures Act ,
Ambulatory Surgery Centers ,
Digital Health ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Information Technologies ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Hospitals ,
Long Term Care Facilities ,
Manufacturers ,
Medical Devices ,
Medicare ,
Medicare Advantage ,
MedPAC ,
Mental Health ,
Mental Health Parity Rule ,
National Institute of Health (NIH) ,
Off-Campus Departments ,
Opioid ,
Patients ,
Pharmaceutical Industry ,
Research and Development ,
Small Business ,
Substance Abuse ,
Telehealth ,
Transparency
On December 14, 2016, President Obama signed the Expanding Capacity for Health Outcomes Act (S. 2873) (the ECHO Act). The ECHO Act seeks to expand the use of health care technology and programming to connect underserved...more
Digital health—the intersection of health care related software applications, analytical tools, medical device technology and electronic data assets that are enabled and achieved through the use of the internet and hand-held...more
Both developers and users of digital health solutions face both immense opportunities and daunting challenges. One key challenge is compliance with the often complex state and federal laws and regulations adopted by the...more
President Obama signed the 21st Century Cures Act on December 13, 2016. The act encourages biomedical research investment and facilitates innovation review and approval processes, but also serves as a vehicle for a wide...more
The promise of health care reform by the incoming administration will result in significant changes; but understanding how those changes may flow through to digital health industry requires an analytic framework that...more
The 21st Century Cures Act encourages biomedical research investment and facilitates innovation review and approval processes, but also serves as a vehicle for a wide variety of other health-related measures, including...more
On December 6, 2016, the House passed the Expanding Capacity for Health Outcomes Act (S. 2873) (the ECHO Act), which was unanimously passed by the Senate on November 29, 2016. The ECHO Act seeks to expand the use of health...more
On December 6, 2016, the US House of Representatives passed the Expanding Capacity for Health Outcomes Act (S. 2873) (the ECHO Act), which was unanimously passed by the US Senate on November 29, 2016. The ECHO Act seeks to...more
Collaborative efforts between congressional offices and various health care stakeholders, as well as the feedback provided in response to the Bipartisan CHRONIC Care Working Group Policy Options Document released in December...more