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201. Medicaid eligibility, enrollment, and renewal processes and systems study: case study summary report--Florida

Author(s):
Zylla, Emily, author
Au-Yeung, Caroline, author
Yukanen, Elizabeth, author
Worrall, Christina, author
Publication:
[Minneapolis, Minnesota] : State Health Access Data Assistance Center, October 19, 2018
Subject(s):
Eligibility Determination
Medicaid -- statistics & numerical data
Electronic Data Processing
Federal Government
Income
Patient Navigation
State Government
Humans
Florida
United States
United States. Department of Health and Human Services.
United States.
State Children's Health Insurance Program (U.S.)

202. Medicaid eligibility, enrollment, and renewal processes and systems study: case study summary report--Idaho

Author(s):
Zylla, Emily, author
Au-Yeung, Caroline, author
Yukanen, Elizabeth, author
Worrall, Christina, author
Publication:
[Minneapolis, Minnesota] : State Health Access Data Assistance Center, October 19, 2018
Subject(s):
Eligibility Determination -- organization & administration
Medicaid -- statistics & numerical data
Electronic Data Processing
Federal Government
Income
Patient Navigation
State Government
Humans
Idaho
United States
United States. Department of Health and Human Services.
United States.
State Children's Health Insurance Program (U.S.)

203. Medicaid eligibility, enrollment, and renewal processes and system study: case study summary report--New York

Author(s):
Zylla, Emily, author
Au-Yeung, Caroline, author
Yukanen, Elizabeth, author
Worrall, Christina, author
Publication:
[Minneapolis, Minnesota] : State Health Access Data Assistance Center, University of Minnesota, October 19, 2018
Subject(s):
Eligibility Determination -- organization & administration
Medicaid -- statistics & numerical data
Electronic Data Processing
Federal Government
Income
Patient Navigation
State Government
Humans
New York
United States
United States. Department of Health and Human Services.
United States.
State Children's Health Insurance Program (U.S.)

204. Medicaid eligibility, enrollment, and renewal processes and systems study: case study summary report--North Carolina

Author(s):
Zylla, Emily, author
Au-Yeung, Caroline, author
Yukanen, Elizabeth, author
Worrall, Christina, author
Publication:
[Minneapolis, Minnesota] : State Health Access Data Assistance Center, October 19, 2018
Subject(s):
Eligibility Determination -- organization & administration
Medicaid -- statistics & numerical data
Electronic Data Processing
Federal Government
Income
Patient Navigation
State Government
Humans
North Carolina
United States
United States. Department of Health and Human Services.
United States.
State Children's Health Insurance Program (U.S.)

205. Opioid use disorders: HHS needs measures to assess the effectiveness of efforts to expand access to medication-assisted treatment : report to majority leader, U.S. Senate

Publication:
Washington, DC : United States Government Accountability Office, October 2017
Subject(s):
Health Services Accessibility
Opiate Substitution Treatment
Opioid-Related Disorders -- drug therapy
Outcome Assessment (Health Care)
Community-Institutional Relations
Buprenorphine -- therapeutic use
Inservice Training
Insurance Coverage
Methadone -- therapeutic use
Naloxone -- therapeutic use
Naltrexone -- therapeutic use
Prescription Drug Diversion -- prevention & control
Humans
United States
United States. Department of Health and Human Services.

206. Medicare and Medicaid: CMS needs to fully align its antifraud efforts with the fraud risk framework : report to Congressional addressees

Publication:
Washington, DC : United States Government Accountability Office, December 2017
Subject(s):
Fraud -- prevention & control
Health Insurance Exchanges
Medicaid
Medicare
Risk Assessment
Risk Management
Fraud -- economics
Humans
United States
United States. Department of Health and Human Services.
Centers for Medicare & Medicaid Services (U.S.)
State Children's Health Insurance Program (U.S.)

207. Pulling together: administrative and budget consolidation of state long-term care services

Publication:
Washington, D.C. : AARP Public Policy Institute, c2006
Subject(s):
Budgets
Long-Term Care -- organization & administration
State Government
Government Agencies -- organization & administration
Medicaid -- economics
Medicare -- economics
Organizational Case Studies
Humans
Minnesota
New Mexico
Oregon
United States
Vermont
Washington
United States. Department of Health and Human Services.

208. Early changes in waivered clinicians and utilization of buprenorphine for opioid use disorder after implementation of the 2021 HHS Buprenorphine Practice Guidelines

Publication:
Washington, D.C. : U.S. Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, December 2, 2022
Subject(s):
Buprenorphine -- therapeutic use
Drug Prescriptions -- statistics & numerical data
Drug Utilization -- statistics & numerical data
Drug Utilization -- trends
Opioid-Related Disorders -- drug therapy
Practice Guidelines as Topic
Scope of Practice
United States
United States. Department of Health and Human Services.

209. Pathological complete response in neoadjuvant treatment of high-risk early-stage breast cancer: use as an endpoint to support accelerated approval

Publication:
[Silver Spring, MD] : United States Food and Drug Administration, Oncology Center of Excellence, July 2020
Subject(s):
Breast Neoplasms
Clinical Trials as Topic
Neoadjuvant Therapy
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

210. Enforcement policy for viral transport media during the Coronavirus disease 2019 (COVID-19) public health emergency: guidance for commercial manufacturers, clinical laboratories, and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, Office of Product Evaluation and Quality, July 2020
Subject(s):
Culture Media
Specimen Handling
Transportation
Virus Diseases
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

211. Regulatory considerations for human cells, tissues, and cellular and tissue-based products: minimal manipulation and homologous use : guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, July 2020
Subject(s):
Biological Products
Tissues
Cell- and Tissue-Based Therapy
Tissue Transplantation
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

212. Cancer clinical trial eligibility criteria: minimum age considerations for inclusion of pediatric patients : guidance for industry and IRBs

Publication:
Silver Spring, MD : United States Food and Drug Administration, Oncology Center of Excellence, July 2020
Subject(s):
Clinical Trials as Topic
Eligibility Determination
Neoplasms
Pediatrics
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

214. Cancer clinical trial eligibility criteria: patients with organ dysfunction or prior or concurrent malignancies

Publication:
[Silver Spring, MD] : United States Food and Drug Administration, Oncology Center of Excellence, July 2020
Subject(s):
Clinical Trials as Topic
Eligibility Determination
Heart Failure
Liver Failure
Neoplasms
Renal Insufficiency
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

215. Marketing status notifications under Section 506I of the Federal Food, Drug, and Cosmetic Act: content and format

Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, August 2020
Subject(s):
Legislation, Drug
Legislation, Food
Marketing -- legislation & jurisprudence
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

216. Enforcement priorities for electronic nicotine delivery systems (ENDS) and other deemed products on the market without premarket authorization (revised)

Publication:
Silver Spring, MD : Center for Tobacco Products, April 2020
Subject(s):
Adolescent Behavior
Adolescent Health
Electronic Nicotine Delivery Systems
Vaping -- prevention & control
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

217. Temporary policy regarding accredited third-party certification program onsite observation and certificate duration requirements during the COVID-19 public health emergency

Publication:
[College Park, MD] : Center for Food Safety and Applied Nutrition, April 2020
Subject(s):
Accreditation -- methods
Certification -- methods
Food Safety
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

218. Temporary policy on repackaging or combining propofol drug products during the COVID-19 public health emergency

Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, Office of Pharmaceutical Quality and Office of Compliance, April 2020
Subject(s):
Drug Packaging -- methods
Propofol -- supply & distribution
COVID-19
Drug Labeling
Pharmacies
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

219. Recommendations to reduce the possible risk of transmission of Creutzfeldt-Jakob disease and variant Creutzfeldt-Jakob disease by blood and blood components

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, August 2020
Subject(s):
Blood Donors
Blood Transfusion
Creutzfeldt-Jakob Syndrome -- prevention & control
Creutzfeldt-Jakob Syndrome -- transmission
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

222. Temporary policy for compounding of certain drugs for hospitalized patients by pharmacy compounders not registered as outsourcing facilities during the COVID-19 public health emergency (revised)

Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, Office of Compliance May 21, 2020
Subject(s):
Drug Compounding -- methods
Hospitalization
Outsourced Services
Pharmacies
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

223. Temporary policy for compounding of certain drugs for hospitalized patients by outsourcing facilities during the COVID-19 public health emergency (revised)

Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, May 21, 2020
Subject(s):
Drug Compounding -- methods
Hospitalization
Outsourced Services
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

224. Enforcement policy for clinical electronic thermometers during the Coronavirus disease 2019 (COVID-19) public health emergency: guidance for Industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, Office of Product Evaluation and Quality, April 2020
Subject(s):
Thermometers -- supply & distribution
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

225. Enforcement policy for extracorporeal membrane oxygenation and cardiopulmonary bypass devices during the Coronavirus disease 2019 (COVID-19) public health emergency: guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, Office of Product Evaluation and Quality April 2020
Subject(s):
Cardiopulmonary Bypass -- instrumentation
Extracorporeal Membrane Oxygenation -- instrumentation
COVID-19 -- therapy
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

226. Cancer clinical trial eligibility criteria: patients with HIV, hepatitis B Virus, or hepatitis C Virus Infections

Publication:
[Silver Spring, MD] : United States Food and Drug Administration, Oncology Center of Excellence, July 2020
Subject(s):
Clinical Trials as Topic
Hepatitis B
Hepatitis C
HIV
Neoplasms
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

229. Policy for temporary compounding of certain alcohol-based hand sanitizer products during the public health emergency: immediately in effect guidance for industry

Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, February 10, 2021
Subject(s):
Drug Compounding -- methods
Ethanol
Hand Sanitizers
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

230. Conventional Foley catheters--performance criteria for safety and performance based pathway: guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, August 14, 2020
Subject(s):
Equipment Design
Equipment Safety
Urinary Catheterization
Urinary Catheters -- standards
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

231. Cutaneous electrodes for recording purposes--performance criteria for safety and performance based pathway: guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, August 14, 2020
Subject(s):
Electrodes
Equipment Design
Equipment Safety
Electrocardiography
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

233. Civil money penalties relating to the ClinicalTrials.gov data bank: guidance for responsible parties, submitters of certain applications and submissions to FDA, and FDA staff

Publication:
Silver Spring, MD : United States Food and Drug Administration, Office of Good Clinical Practice. August 2020
Subject(s):
Clinical Trials as Topic
Databases as Topic
Data Management -- legislation & jurisprudence
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

236. Enforcement policy for infusion pumps and accessories during the Coronavirus disease 2019 (COVID-19) public health emergency: guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, Office of Product Evaluation and Quality, April 2020
Subject(s):
Infusion Pumps
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

237. Enforcement policy for remote ophthalmic assessment and monitoring devices during the coronavirus disease 2019 (COVID-19) public health emergency: guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, Office of Product Evaluation and Quality 2020
Subject(s):
Remote Consultation
Telemedicine -- instrumentation
Tonometry, Ocular -- instrumentation
Vision Tests -- instrumentation
Wireless Technology -- instrumentation
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

238. Temporary policy regarding non-standard PPE practices for sterile compounding by pharmacy compounders not registered as outsourcing facilities during the COVID-19 public health emergency

Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, Office of Compliance, April 2020
Subject(s):
Drug Compounding -- methods
Personal Protective Equipment -- supply & distribution
COVID-19
Sterilization -- methods
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

239. Policy for the temporary use of portable cryogenic containers not in compliance with 21 CFR 211.94(e)(1) for oxygen and nitrogen during the COVID-19 public health emergency

Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, April 2020
Subject(s):
Nitrogen -- supply & distribution
Oxygen -- supply & distribution
COVID-19
Nitrogen -- therapeutic use
Oxygen -- therapeutic use
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

240. Providing regulatory submissions for medical devices in electronic format: submissions under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act : guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, July 15, 2020
Subject(s):
Electronic Data Processing -- legislation & jurisprudence
Legislation, Drug
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

241. Clinical investigations for prostate tissue ablation devices: guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, July 15, 2020
Subject(s):
Clinical Studies as Topic
High-Intensity Focused Ultrasound Ablation
Prostate -- surgery
Prostatic Neoplasms -- prevention & control
Prostatic Neoplasms -- surgery
Therapies, Investigational
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

242. Unique device identification: policy regarding compliance dates for class I and unclassified devices and certain devices requiring direct marking : immediately in effect guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, July 1, 2020
Subject(s):
Equipment and Supplies -- standards
Medical Device Legislation
Product Labeling
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

245. Institutional review board (IRB) review of individual patient expanded access requests for investigational drugs and biological products during the COVID-19 public health emergency: guidance for IRBs and clinical investigators

Publication:
[Silver Spring, MD] : Oncology Center of Excellence, June 2020
Subject(s):
Biological Products -- therapeutic use
COVID-19 -- drug therapy
Drugs, Investigational
Ethics Committees, Research
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

246. Temporary policy regarding preventive controls and FSVP food supplier verification onsite audit requirements during the COVID-19 public health emergency: guidance for industry

Publication:
[Silver Spring, MD] : Center for Food Safety and Applied Nutrition, June 2020
Subject(s):
Animal Feed -- supply & distribution
Food Handling
Food Supply
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

248. Patient-focused drug development: collecting comprehensive and representative input : guidance for industry, Food and Drug Administration staff, and other stakeholders

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, June 2020
Subject(s):
Drug Development
Feedback
Sampling Studies
Patient Reported Outcome Measures
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

251. Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia: developing drugs for treatment

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, June 2020
Subject(s):
Drug Development
Healthcare-Associated Pneumonia -- drug therapy
Pneumonia, Bacterial -- drug therapy
Pneumonia, Ventilator-Associated -- drug therapy
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

252. Good manufacturing practice considerations for responding to COVID-19 infection in employees in drug and biological products manufacturing

Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, June 2020
Subject(s):
Biological Products
COVID-19 -- prevention & control
Drug Industry
Manufacturing and Industrial Facilities
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

253. Enforcement policy for non-invasive remote monitoring devices used to support patient monitoring during the coronavirus disease 2019 (COVID-19) public health emergency (revised): guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, October 2020
Subject(s):
COVID-19
Monitoring, Physiologic
Remote Sensing Technology
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

254. Temporary policy for preparation of certain alcohol-based hand sanitizer products during the public health emergency (COVID-19)

Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, February 10, 2021
Subject(s):
Drug Compounding -- methods
Drug Compounding -- standards
Ethanol
Hand Sanitizers
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

255. Policy for temporary compounding of certain alcohol-based hand sanitizer products during the public health emergency: immediately in effect guidance for industry

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, February 10, 2021
Subject(s):
Drug Compounding -- methods
Drug Compounding -- standards
Ethanol
Hand Sanitizers
Methanol
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

257. Cytomegalovirus in transplantation: developing drugs to treat or prevent disease

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, May 2020
Subject(s):
Cytomegalovirus Infections -- drug therapy
Cytomegalovirus Infections -- prevention & control
Organ Transplantation
Stem Cell Transplantation
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

259. COVID-19 public health emergency: general considerations for pre-IND meeting requests for COVID-19 related drugs and biological products : guidance for industry and investigators

Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, May 2020
Subject(s):
Biological Products
COVID-19 -- drug therapy
Drug Approval
Drug Industry
Drugs, Investigational
Drug Evaluation, Preclinical
Investigational New Drug Application
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

260. Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, May 2020
Subject(s):
Device Approval
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

261. Postmarketing adverse event reporting for medical products and dietary supplements during a pandemic

Publication:
Silver Spring, MD : Office of Counterterrorism and Emerging Threats, May 2020
Subject(s):
Dietary Supplements -- adverse effects
Drug-Related Side Effects and Adverse Reactions
Equipment Design -- adverse effects
Equipment Safety
Product Surveillance, Postmarketing
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

262. Policy for coronavirus disease-2019 tests during the public health emergency (revised): immediately in effect guidance for clinical laboratories, commercial manufacturers, and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, May 11, 2020
Subject(s):
Clinical Laboratory Techniques
COVID-19 Serological Testing
COVID-19 Testing
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

264. Submission of plans for cigarette packages and cigarette advertisements (revised)

Publication:
Silver Spring, MD : Center for Tobacco Products, July 2021
Subject(s):
Cigarette Smoking -- adverse effects
Cigarette Smoking -- prevention & control
Product Packaging
Tobacco Products -- adverse effects
Tobacco Products -- supply & distribution
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

265. Required warnings for cigarette packages and advertisements: small entity compliance guide (revised)

Publication:
Silver Spring, MD : Center for Tobacco Products, July 2021
Subject(s):
Cigarette Smoking -- adverse effects
Cigarette Smoking -- prevention & control
Product Packaging
Tobacco Products -- adverse effects
Tobacco Products -- supply & distribution
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

266. Enforcement policy for face masks and respirators during the coronavirus disease (COVID-19) public health emergency (revised): guidance for industry and food and drug administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, May 2020
Subject(s):
COVID-19 -- prevention & control
Masks
N95 Respirators
Personal Protective Equipment
Respiratory Protective Devices
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

269. Wholesale distributor verification requirement for saleable returned drug product and dispenser verification requirements when investigating a suspect or illegitimate product: compliance policies

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, October 2020
Subject(s):
Drug Industry
Drug and Narcotic Control
Pharmaceutical Preparations
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

270. Technical considerations for non-clinical assessment of medical devices containing nitinol: guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, July 9, 2021
Subject(s):
Alloys
Equipment Design
Equipment Safety
Nickel
Titanium
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

271. Necessary automated external defibrillator accessories: policy regarding compliance date : guidance for industry, stakeholders, health care professionals, and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, October 28, 2020
Subject(s):
Defibrillators
Device Approval
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

273. Certificates of confidentiality: guidance for sponsors, sponsor-investigators, researchers, industry, and food and drug administration staff

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research September 2020
Subject(s):
Biomedical Research
Confidentiality
Privacy
Research Subjects
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

276. Assessing COVID-19-related symptoms in outpatient adult and adolescent subjects in clinical trials of drugs and biological products for COVID-19 prevention or treatment

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, September 2020
Subject(s):
Clinical Trials as Topic
COVID-19 -- drug therapy
COVID-19 -- prevention & control
Outpatients
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

278. Importation of certain FDA approved human prescription drugs, including biological products, and combination products under section 801(d)(1)(b) of the Federal Food, Drug, and Cosmetic Act

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, September 2020
Subject(s):
Biological Products
Drug Labeling
Prescription Drugs
Counterfeit Drugs
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

279. Recognition and withdrawal of voluntary consensus standards: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, September 15, 2020
Subject(s):
Consensus
Equipment and Supplies -- standards
Voluntary Programs -- standards
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

280. The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: guidance for industry, accreditation bodies, testing laboratories, and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, September 25, 2020
Subject(s):
Accreditation
Equipment and Supplies
Materials Testing
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

281. Basic safety and essential performance of medical electrical equipment, medical electrical systems, and laboratory medical equipment: standards specific information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program : guidance for industry, accreditation bodies, testing laboratories, and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, September 25, 2020
Subject(s):
Accreditation
Electricity
Equipment Safety
Equipment and Supplies
Mechanical Tests
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

282. Biocompatibility testing of medical devices: standards specific information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program : guidance for industry, accreditation bodies, testing laboratories, and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, September 25, 2020
Subject(s):
Accreditation
Equipment and Supplies
Materials Testing -- standards
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

284. Breast implants: certain labeling recommendations to improve patient communication : guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, September 29, 2020
Subject(s):
Breast Implants
Equipment Safety
Product Labeling
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

285. Self-monitoring blood glucose test systems for over-the-counter use: guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, September 29, 2020
Subject(s):
Blood Glucose Self-Monitoring
Device Approval
Equipment Safety
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

286. Use of International Standard ISO 10993-1: "Biological evaluation of medical devices - part 1 : evaluation and testing within a risk management process" : guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, September 4, 2020
Subject(s):
Device Approval
Equipment Failure
Equipment Safety
Equipment and Supplies -- standards
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

288. Hospital capabilities to enable patient electronic access to health information: 2019

Author(s):
Johnson, Christian, MPH (based on t.p. from bib 9918317680806676), author
Barker, Wesley, author
Publication:
Washington, DC : U.S. Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, June 2021
Subject(s):
Access to Information
Electronic Health Records
Hospitals -- statistics & numerical data
Patient Portals -- statistics & numerical data
United States
United States. Department of Health and Human Services.

289. Challenges to public health reporting experienced by non-federal acute care hospitals: 2019

Author(s):
Richwine, Chelsea, author
Marshall, Carmelita, author
Jensen, Christian, 1833-1916, author
Patel, Vaishali, author
Publication:
Washington, DC : U.S. Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, September 2021
Subject(s):
Health Information Interoperability
Hospitals
Information Dissemination
Mandatory Reporting
Public Health
Public Health Surveillance
COVID-19
Health Facility Size
State Government
United States
United States. Department of Health and Human Services.

290. Individuals' access and use of patient portals and smartphone health apps: 2020

Author(s):
Johnson, Christian, MPH (based on t.p. from bib 9918317682006676), author
Richwine, Chelsea, author
Patel, Vaishali, author
Publication:
Washington, DC : Office of the National Coordinator for Health Information Technology, September 2021
Subject(s):
Facilities and Services Utilization -- statistics & numerical data
Mobile Applications
Patient Portals
Smartphone
Physician's Role
United States
United States. Department of Health and Human Services.

291. Delivery reform

Author(s):
Raduege, Tammy J., author
Publication:
[Toronto, Ontario] : Thomson Reuters, 20-December-2021
Subject(s):
Delivery of Health Care -- organization & administration
Health Care Reform -- legislation & jurisprudence
Accountable Care Organizations
Electronic Health Records
Federal Government
Maternal Health
Medicare
State Government
United States
United States. Department of Health and Human Services.
United States.
Centers for Medicare & Medicaid Services (U.S.)

292. Administrative rulemaking

Author(s):
Berry, Melissa D, author
Publication:
[Toronto, Ontario] : Thomson Reuters, 20-December-2021
Subject(s):
Health Care Reform -- legislation & jurisprudence
Health Insurance Exchanges -- legislation & jurisprudence
Insurance, Health -- legislation & jurisprudence
Legislation, Medical
COVID-19
Health Information Interoperability
Medicaid -- legislation & jurisprudence
Medicare -- legislation & jurisprudence
United States
United States. Department of Health and Human Services.
United States.

293. Interoperability among office-based physicians in 2015 and 2017

Author(s):
Patel, Vaishali, author
Pylypchuk, Yuriy, author
Parasrampuria, Sonal, author
Kachay, Lolita, author
Publication:
Washington, D.C. : U.S. Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, May 2019
Subject(s):
Electronic Health Records -- trends
Health Information Interoperability -- trends
Information Dissemination
Practice Patterns, Physicians' -- trends
United States
United States. Department of Health and Human Services.

294. Trends in individuals' access, viewing and use of online medical records and other technology for health needs: 2017-2018

Author(s):
Patel, Vaishali, author
Johnson, Christian, MPH, author
Publication:
Washington, DC : U.S. Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, May 2019
Subject(s):
Electronic Health Records -- statistics & numerical data
Electronic Health Records -- trends
Mobile Applications
Smartphone
United States
United States. Department of Health and Human Services.

295. Electronic prescribing of controlled substances among office-based physicians: 2017

Author(s):
Parasrampuria, Sonal, author
Blanco, Martin, author
Barker, Wesley, author
Publication:
Washington, DC : U.S. Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, September 2019
Subject(s):
Controlled Substances
Electronic Prescribing -- statistics & numerical data
Practice Patterns, Physicians' -- statistics & numerical data
Prescription Drug Diversion -- prevention & control
Electronic Health Records
Medicare Part D
United States
United States. Department of Health and Human Services.

296. Access and use of electronic health information by individuals with cancer: 2017-2018

Author(s):
Johnson, Christian, MPH, author
Krakow, Melinda, author
Patel, Vaishali, author
Publication:
Washington, DC : U.S. Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, January 2020
Subject(s):
Electronic Health Records -- statistics & numerical data
Facilities and Services Utilization -- statistics & numerical data
Health Services Accessibility -- statistics & numerical data
Neoplasms
United States
United States. Department of Health and Human Services.

297. State of Interoperability among U.S. non-federal acute care hospitals in 2018

Author(s):
Pylypchuk, Yuriy, author
Johnson, Christian, MPH, author
Patel, Vashali, author
Publication:
Washington, DC : U.S. Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, March 2020
Subject(s):
Electronic Health Records -- statistics & numerical data
Health Information Interoperability -- statistics & numerical data
Hospitals -- statistics & numerical data
Information Dissemination
United States
United States. Department of Health and Human Services.

298. Variation in methods for health information management among U.S. substance abuse treatment centers: 2017

Author(s):
Barker, Wesley, author
Christian Johnson, MPH, author
Publication:
Washington, DC : U.S. Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, July 2020
Subject(s):
Electronic Health Records -- statistics & numerical data
Health Information Management -- methods
Information Dissemination -- methods
Substance Abuse Treatment Centers -- statistics & numerical data
United States
United States. Department of Health and Human Services.

299. Individuals' use of online medical records and technology for health needs

Author(s):
Patel, Vaishali, author
Johnson, Christian, MPH, author
Publication:
Washington, DC : U.S. Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, April 2018
Subject(s):
Electronic Health Records -- statistics & numerical data
Mobile Applications
Patient Portals
Smartphone
United States
United States. Department of Health and Human Services.

300. Electronic health record adoption and interoperability among U.S. skilled nursing facilities and home health agencies in 2017

Author(s):
Henry, JaWanna, author
Pylypchuk, Yuriy, author
Patel, Vaishali, author
Publication:
Washington, DC : U.S. Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, November 2018
Subject(s):
Electronic Health Records -- statistics & numerical data
Health Information Interoperability -- statistics & numerical data
Home Care Services -- statistics & numerical data
Skilled Nursing Facilities -- statistics & numerical data
Diffusion of Innovation
United States
United States. Department of Health and Human Services.