A final rule has been released by the FDA for the simplification of its medical device classification and reclassification procedures. The rule clarifies that the agency can reclassify any device from Class III to either Class II or Class I, makes convening a panel to consult on a device reclassification optional and removes the two-form requirement for reclassification petitions.
A report from Deloitte describes how cybercriminals use and adapt readily available tools and services, often with minimal expertise. Simple phishing and data harvesting tools are available for less than $30, and ransomware tools are available starting at about $390.
An interagency collaboration called TOP Health has delivered results since it was launched in October, says Gil Alterovitz, a Presidential Innovation Fellow working with the Department of Veterans Affairs, including three clinical trial datasets in machine-readable format from which Flatiron Health, Microsoft Healthcare, Oracle, Philips, Rush Medical and TrialX developed artificial intelligence tools. TOP Health's goal is to develop a testing platform and standard protocols for AI applications, Alterovitz says.
A Black Book survey of health care executives found that an EHR implementation or replacement caused concerns about the future of their employment in 64% of respondents, while 5% reported that they or their colleagues were asked to resign or were fired because of the effect of EHR rollouts on costs or productivity. Ninety-three percent of respondents had little regret over their choice of EHR vendor, but 88% of those from smaller regional health systems expressed dissatisfaction, listing issues such as physician and clinical burnout, hidden costs, reliability issues, consumer frustration and time-extended rollouts.
The new Physician Fee Schedule from the Centers for Medicare and Medicaid Services will ease some burdens for practices but improvements are still needed, writes Anders Gilberg, senior vice president of government affairs for the Medical Group Management Association. "CMS must work with the physician community to meaningfully reduce the regulatory burden and allow practices to allocate precious time and resources to providing high-quality care that meets the needs of their unique patient population," he writes.
Atul Gawande, leader of the healthcare partnership between Amazon, JPMorgan Chase and Berkshire Hathaway, has long been a critic of the US healthcare model and is expected to create a value-based model that reflects his views. While little is known about his plan, Gawande's previous publications and interviews provide insight into the possibilities, which could include some form of an integrated care model.
Several trends are reshaping the US healthcare industry, including rising consumerism among patients, inflating healthcare expenses and traditional providers' yielding of their lead role in healthcare to outside firms -- all of which are contributing to a shift in the industry's focus from caring for the sick to maintaining patients' health. This transformation will be driven by organizations' effective use of technology and patient data.
Healthcare industry leaders and stakeholders have until Feb. 11, 2019, to comment on a request for information released by HHS and the Office for Civil Rights about a HIPAA guidance update for data sharing and how HIPAA and the HITECH Act can be considered for information disclosures. "We are committed to pursuing the changes needed to improve quality of care and eliminate undue burdens on covered entities while maintaining robust privacy and security protections for individuals' health information," said OCR Director Roger Severino.
Physicians wanting to expand their practice can apply for a loan from the Small Business Administration or take a more traditional route with a bank loan, where they will have a variety of options. Practice members should agree on a repayment formula before taking out a loan, and should get advice from a healthcare lawyer before finalizing the formula.
A Spok survey of CHIME member CIOs compared the executives' predictions and priorities going into 2018 with their progress as the year comes to a close. The survey found that the top priority among CIOs this year was integrating patient monitoring data instead of EHR integration as previously predicted, 100% of CIOs see data analytics as a priority in 2019 compared with just 40% last year, and cybersecurity spending in 2019 is expected to increase among 87% of respondents.