Today, FDA published a notice in the Federal Register announcing a public workshop on July 11-12 entitled “Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regulatory Purposes.” This workshop builds on FDA’s ongoing efforts to implement the Real-World Evidence (RWE) Framework published in December 2018, which we previously discussed in this post. According to … Continue Reading
On Friday, April 19, 2019, the Office for Civil Rights of the U.S. Department of Health and Human Services (HHS) explained in an FAQ the circumstances under which electronic health record (EHR) systems may be subject to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) liability for an app’s impermissible use or disclosure … Continue Reading
On April 19, 2019, the Department of Health and Human Services (HHS) announced a 30-day extension to the comment period for two rules proposed by the HHS Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC), originally published on March 4, 2019. These rules, discussed … Continue Reading
Following on from the Evidence Standards Framework for DHTs published in December 2018 (the Original Standards, as reported in our previous blog post, here), the UK’s National Institute for Health and Care Excellence (NICE) recently published a newly updated version of the standards (the Updated Standards, available here). The Updated Standards were produced following feedback … Continue Reading
On March 4, 2019, the Department of Health and Human Services (HHS) published two proposed rules to improve patient access to personal health data. The two rules, issued by the HHS Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC), are intended to increase interoperability … Continue Reading
The UK’s National Institute for Health and Care Excellence (NICE) has recently published an evidence standards framework for DHTs (the Standards), available here. It did so through a working group led by NHS England, but supported by representatives from Public Health England, MedCity and DigitalHealth.London. The Standards cover DHTs, such as apps, programs and software … Continue Reading
On the April 25, 2018 the European Commission (the “Commission”) adopted a plan of action to enable the digital transformation of health and care in the Digital Single Market (the “Communication”), intended to put EU citizens at the centre of the healthcare system. This is to be achieved in three ways: 1. Citizens’ secure access … Continue Reading
On March 6, 2018, CMS announced the MyHealthEData initiative, which aims to give patients easier access to and control over their medical records. Announcing the initiative, CMS Administrator Seema Verma laid out a future where individuals will have access to their health data wherever they go and be able to share data with the push … Continue Reading
As 2018 gets underway, EHR vendors and users continue to face challenges and uncertainty. There are three legal and regulatory issues in particular that we think are important to watch over the next 10 months:… Continue Reading
Technology companies widely use open source software (“OSS”), which carries with it many potential benefits. It can reduce the time and cost of development, and, to the extent that the code has been vetted by numerous other developers, may contain fewer bugs. OSS can also reduce dependency upon third party vendors and associated pricing risks. … Continue Reading
The full Senate could vote as early as this week on the nomination of Rep. Tom Price (R-GA) to be Secretary of the U.S. Department of Health and Human Services (HHS). In January, two Senate Committees held hearings on Rep. Price’s nomination. These hearings focused largely on Rep. Price’s stance on repeal of the Affordable … Continue Reading
Tom Price, the Republican representative from Georgia, has been tapped by President-elect Trump as the new Secretary for the Department of Health and Human Services (HHS). Rep. Price is himself an orthopedic surgeon and comes from a family of doctors and, as a result, is focused closely on the ways in which government regulations burden … Continue Reading
Last month, the Department of Health and Human Services’ Office of the National Coordinator for Health Information Technology (ONC) released a new guide for prospective buyers of Electronic Health Record systems (EHRs). ONC provides detailed information and suggestions that merit the serious consideration of anyone that contracts or plans to contract with an EHR vendor. … Continue Reading
Earlier this week the Government Accountability Office released a report critiquing the U.S. Department of Health and Humana Services’ (HHS) oversight of and guidance related to health information security and privacy. (The report is available here.) GAO cited the increasing incidence of hacking and other breaches, which affected over 113 million health records in 2015, … Continue Reading
Last month, the Office of Management and Budget (“OMB”) began its review of the much-discussed new Health IT Certification regulations, which include enhanced oversight of Electronic Health Records (“EHRs”) technology by the Office of the National Coordinator for Health Information Technology (“ONC”).… Continue Reading
This past Spring, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) again identified EHR-related fraud as a problem area. Particularly in light of the OIG’s continued focus on this issue, providers would be well-advised to work on strategies to mitigate the risk of EHR fraud.… Continue Reading
On Friday, on the InsideMedicalDevices blog, our colleagues posted a summary and analysis of the FDA’s draft guidance encouraging clinical investigators to make their electronic data capture systems interoperable with health care organizations’ electronic health records. To read the post, please click here.… Continue Reading
In March, CMS issued a State Medicaid Directors Letter (SMDL) about the availability of enhanced federal funding for state Medicaid programs’ eligibility and enrollment (E&E) systems. This SMDL represents CMS’s most recent effort to encourage States to use commercial “off-the-shelf” technology and “software as a service,” instead of customized electronic systems developed and built specifically … Continue Reading
On February 29, 2016, the Centers for Medicare and Medicaid Services (CMS) issued a State Medicaid Directors Letter (SMDL) that expands the scope of expenditures eligible for the 90 percent federal match for activities to promote the use of a health information exchange (HIE) and the adoption of certified electronic health record (EHR) technology by … Continue Reading
Last month, the Department of Health and Human Services (HHS) announced that a number of large health care companies and providers had “agreed to implement three core commitments” to improve access to electronic health records (EHR). HHS touted the commitments as a significant step toward increased EHR interoperability.… Continue Reading
On March 27, 2016, New York became the first State to require electronic prescribing for both controlled and non-controlled substances and to provide for civil and criminal penalties for doctors failing to comply. Electronic prescribing means the patient no longer receives a paper prescription; rather, he or she chooses a pharmacy to which the electronic … Continue Reading
On February 11, the Centers for Medicare & Medicaid Services (CMS) extended the attestation deadline for health-care providers in the Electronic Health Records (EHR) Meaningful Use program. Originally, providers were required to attest that they met the requirements of the Meaningful Use Program by next Monday, February 29, 2016. That deadline has been extended by … Continue Reading
This week, Centers for Medicare & Medicaid Services (CMS) Acting Administrator Andy Slavitt set forth guiding principles that CMS will consider in crafting regulations implementing the Medicare Access and CHIP Reauthorization Act (MACRA). In January, Administrator Slavitt announced the end of the Electronic Health Records (EHR) Meaningful Use Program, which would instead be replaced by … Continue Reading
On January 22, 2016, the Centers for Medicare & Medicaid Services (“CMS”) announced the launch of a new, streamlined application process for providers and hospitals seeking a hardship exception from financial penalties for failing to meet meaningful use electronic health record requirements. According to CMS, “[t]he streamlined hardship applications reduce the amount of information that … Continue Reading
